MalfunctionMDM
OSTEOTOME, ANKLE ARTHRO SCOPY, CURVED
Received Jul 7, 2026 · Event occurred Jun 1, 2026
Report 1220246-2026-03638 · MDR key 25734671
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
OSTEOTOME, ANKLE ARTHRO SCOPY, CURVEDCatalog number
AR-8655-09
Lot number
1392209
Product problems
- Break
Patient
Not reported
- 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
IT WAS REPORTED THAT DURING AN ANKLE ARTHRODESIS SURGERY THE TIP OF THE DEVICE BROKE. ALL PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH AN UNKNOWN DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.