DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO
Received Feb 2, 2026 · Event occurred Jan 12, 2026
Report 1220246-2026-00359 · MDR key 24238668
Device
Generic name
Depth Gauge
Manufacturer
Arthrex, Inc.Model number
DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PROCatalog number
AR-8943-15
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 12-JAN-2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE FROM AN RAR-9943S LOANER ANKLE FRACTURE SET SN: 14188044 HAD A BROKEN THREADED RING THAT KEEPS THE STICK IN PLACE. IT WAS REPORTED THAT THEY WERE UNSURE IF THE RING HAPPENED TO BE THE WRONG SIZE OR WAS ACTUALLY BROKEN. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD DATA, ARTHREX CONCLUDED THE MOST LIKELY CAUSE OF THE REPORTED FAILURE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A USER ERROR, INCLUDING DAMAGE TO THE DEVICE DUE TO MISHANDLING. THE COMPLAINT ALLEGATION WAS CONFIRMED BASED ON THE CUSTOMER'S ATTACHED VIDEO, WHICH SHOWS THE DEVICE'S NEEDLE DETACHED FROM THE SHAFT. DAMAGE TO THE DEVICE WILL PREVENT THE DEVICE FROM WORKING AS INTENDED.