Fasteners for Medical Device Manufacturing

Chain of Custody (CoC) Documentation

Chain of Custody (CoC) documentation is a detailed record that traces the possession, handling, and location of an item throughout its lifecycle. This ensures that every entity handling the fastener, from manufacture to end use, is held accountable. It provides a clear history of the fastener, including manufacturing details, quality checks, and distribution.
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Mil-Spec Fasteners

Mudge Fasteners offers a wide variety of military grade fasteners, including MS, NAS, AN and NASM. Some items available in mil-spec are machine screws, socket cap screws, self-tapping screws, finished hex nuts, nylon insert locknuts, lock washers, tooth washers, flat washers, pins and more.
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PTFE
Polytetrafluoroethylene (PTFE) is a thermoplastic polymer valued for its exceptional strength, toughness, low friction, biocompatibility, and chemical inertness. Its non-adhesive properties make it effective at resisting the attachment of bacteria and other infectious agents. Due to its biocompatibility and inert nature, PTFE is predominantly utilized in surgical procedures and soft tissue implants as a graft material.

PEEK
Developed in the 1970s for the aerospace industry, Polyether Ether Ketone (PEEK) stands out as a high-strength, high-temperature polymer with versatile applications. Over two decades later, a highly pure, implantable grade of PEEK was introduced, quickly becoming a standard in medical devices. In the early 2000s, carbon-fiber reinforced PEEK entered the medical field. Today, PEEK is widely used in various implants, particularly spinal implants, bone fixation screws, and dental implants. Its increasing popularity can be attributed to several factors:

• Better compatibility with diagnostic imaging compared to metal implants—PEEK’s transparency to X-rays prevents image distortion, even during CT and MRI scans.

• Biocompatibility and stability in biological environments.

• High strength and stiffness, making it a suitable replacement for metals in certain applications.

• Excellent resistance to fatigue, creep, and wear.

• Chemical resistance and the ability to be sterilized using common methods.

Titanium
Titanium is prized for its high strength-to-weight ratio and excellent biocompatibility, making it ideal for numerous medical applications. Titanium Grade 23, also known as TI 6AL-4V ELI, is an Extra Low Interstitial grade and is often regarded as medical-grade titanium. This material is frequently used for joint replacements and dental implants, with some implants lasting up to 20 years.

• Its biocompatibility allows for a structural and functional connection between living bone and the surface of a load-bearing artificial implant.

• Titanium is 60% denser than aluminum yet more than twice as strong, contributing to its high strength-to-weight ratio.

• Its low density and ductility help prevent cracking.

• Titanium is non-magnetic and non-ferromagnetic, ensuring safe imaging with MRI.

Tantalum
Tantalum is widely recognized in industry for its exceptional corrosion resistance and chemical inertness. In the medical field, tantalum is also known as one of the most biocompatible metals because it remains non-reactive within the human body. Its non-irritating properties promote rapid bone growth, making it ideal for use in orthopedic and spinal implants.

• Exceptional inertness and biocompatibility.

• Dense, ductile, and hard.

• Ability to bond directly to hard tissue.

• Non-irritating and resistant to bodily fluids.

MP35N
MP35N is a superalloy composed of nickel, cobalt, chromium, and molybdenum, known for its remarkable combination of high strength, toughness, ductility, and corrosion resistance. In the medical field, MP35N is valued for its extreme tensile strength, ranging from 227 ksi to 294 ksi when age-hardened. Its biocompatibility is also crucial, making it a preferred material for orthodontic braces and prosthetics that require strength and ductility to endure the demands of their applications.

Miniature Security Screws

Miniature security fasteners from Mudge fit tight, torque high, and have unrivaled security - bits are never sold retail and the drives are designed to repel other bits and tools. Miniature security screws for medical devices are available in metric or imperial sizes, and in machine or plastic thread.

Additional Materials

• A307 A

• A307 B

• A193 / A194 B7

• A193 / A194 B8, B8M, B8M Class 2

• F593 / 594 T-304 & T-316

• A325

• SAE J429 Grade 2, 5, 8

• F469 / 467 Silicone Bronze (Red Brass)

Additional Services

• Chain of Custody documentation

• Double bagged fasteners

• Plastic lined boxes

• Lot controlled items

• Custom kitting

• Country of Origin labeling on boxes

• Country of Origin labeling on pallets