inforMED
MalfunctionHTW

3.0MM DRILL BIT

Received Jul 7, 2026 · Event occurred Jun 9, 2026

Report 1220246-2026-03633 · MDR key 25732927

Device

Generic name

Orthopedic Manual Surg Instr

Manufacturer

Arthrex, Inc.

Model number

3.0MM DRILL BIT

Catalog number

AR-9628

Lot number

022444

Product problems

  • Break

Patient

Not reported

  • Foreign Body In Patient

Narrative

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGERY, THE DRILL TIP BROKE OFF WHILE DRILLING INTO VERY HARD GLENOID BONE AND REMAINED IN THE BONE. NO FURTHER INFORMATION WAS RECEIVED. UPDATE 12-JUN-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE MODULAR GLENOID SYSTEM SURGERY, THE DRILL TIP BROKE OFF WHILE DRILLING INTO VERY HARD GLENOID BONE AND REMAINED IN THE BONE. THE DRILL BROKE OFF DURING THE FINAL DRILLING OPERATION. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.