MalfunctionHTJ
DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO
Received Jul 13, 2026 · Event occurred Jun 12, 2026
Report 1220246-2026-03764 · MDR key 25802522
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
012511
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 17-JUN-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8943-15 LOW PRO DEPTH DEVICE (FROM 3.5/4.0 CFS SET #1 - AR-8950S-02) CAME APART AFTER PROVIDING INCORRECT MEASUREMENTS FOR 2 SCREWS DURING A LISFRANC ORIF PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT AFFECTED.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.