DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO
Received Apr 9, 2026 · Event occurred Mar 19, 2026
Report 1220246-2026-02126 · MDR key 24834922
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
012431
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 19-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE BROKE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION PROVIDED 25-MAR-2026: IT WAS FURTHER REPORTED THE BREAK OCCURRED WHEN THE THIN ARM OF THE DEPTH DEVICE MET THE BODY THAT HAS NUMBERS ON IT. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE ORIF PROCEDURE WHILE THE SURGEON WAS TRYING TO MEASURE THE LENGTH OF THE SCREW HOLE. NO PATIENT HARM AND NO CASE DELAY WAS REPORTED. ALL FRAGMENTS WERE RETRIEVED.