inforMED
MalfunctionMDM

T20 HEXALOBE DRIVER

Received Feb 3, 2026 · Event occurred Nov 20, 2025

Report 1220246-2026-00386 · MDR key 24251573

Device

Generic name

Manual Instr, General Surgical

Manufacturer

Arthrex, Inc.

Catalog number

AR-8970-03

Lot number

1392421

Product problems

  • Dull, Blunt

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE REPORTED EVENT WAS CONFIRMED AS THE EVALUATION REVEALED THAT THE DRIVE GEOMETRY AT THE DISTAL TIP IS TWISTED AND THEREFORE THE SCREWDRIVER CANNOT GRIP THE SCREW PROPERLY (SEE EVALUATION PICTURES 3 + 4). THE COMPLAINANT'S EVENT IS MOST LIKELY CAUSED BY OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGERY THE SCREWDRIVERS WERE HEAVILY WORN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.