MalfunctionHTW

DRILL BIT SQC 2.5MM 110/32MM

Received Mar 18, 2025

Report 2249529-2025-00002 · MDR key 21638664

Device

Generic name

Drill Bit Sqc

Manufacturer

Gsource, Llc

Model number

GS 86.8226

Product problems

Break
Break

Patient

NA · Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

IT WAS A COMPLAINT ABOUT 3 DRILLS BROKE DURING SURGERY; DIFFERENT SURGERIES AND DIFFERENT SURGEONS. BROKEN DRILL BIT DID NOT REMAINED IN ANY PATIENT'S BODY.

Additional Manufacturer Narrative

REFER TO COMPLAINT FILE: (B)(4).