MalfunctionHTJ
DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO
Received Mar 5, 2026 · Event occurred Feb 11, 2026
Report 1220246-2026-01234 · MDR key 24518712
Device
Generic name
Depth Gauge
Manufacturer
Arthrex, Inc.Model number
DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PROCatalog number
AR-8943-15
Lot number
012351
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE ANKLE JOINT SURGERY, THE HOOK OF THE DEVICE BROKE OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.