inforMED
MalfunctionHTW

2.7MM DRILL BIT, CMP FT, CALIBRATED

Received Jul 17, 2026 · Event occurred Oct 3, 2025

Report 1220246-2026-03881 · MDR key 25854303

Device

Generic name

Drill Bit

Manufacturer

Arthrex, Inc.

Catalog number

AR-8737-35

Lot number

021627

Product problems

  • Break

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

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

ON 25TH JUNE 2026, IT WAS REPORTED BY A DISTRIBUTOR VIA AN EMAIL THAT FOR 1 UNIT OF AR-8737-35, DRILL BIT, CANNULATED, 2.7 MM, THE DRILL BIT BROKE AND WAS LODGED INSIDE THE WORKING CHANNEL. NO FRAGMENTS REMAINED IN THE PATIENT. THIS WAS DETECTED DURING A CONPRESSION FT ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE BROKEN DRILL BIT WAS STOPPED FROM USE IMMEDIATELY AND REPLACED WITH A NEW DRILL BIT. THERE WAS NO PATIENT HARM.