inforMED
MalfunctionHTW

POWER SCREWDRIVER 2.5/2.8

Received Jul 12, 2022 · Event occurred Jun 27, 2022

Report MW5110825 · MDR key 15003328

Device

Generic name

Bill, Drill

Manufacturer

Medartis, Inc.

Model number

A-2013

Lot number

1994340

Product problems

  • Break

Patient

49 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING DISTAL RADIUS ORIF (OPEN REDUCTION AND INTERNAL FIXATION) PROCEDURE A SCREWDRIVER TIP BROKE OFF THE END OF THE SCREWDRIVER. FDA SAFETY REPORT ID# (B)(4).