DYNANITE PIP - BENT 14MM - W/INSTR
Received May 18, 2026 · Event occurred Apr 29, 2026
Report 1220246-2026-02887 · MDR key 25199805
Device
Generic name
Smooth Fixation Pin
Manufacturer
Arthrex, Inc.Model number
DYNANITE PIP - BENT 14MM - W/INSTRCatalog number
AR-4158DS-14B
Lot number
15047376
Product problems
- Positioning Failure
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 29-APR-2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA PHONE THAT AN AR-4158DS-14B DYNANITE PIP KIT HAD AN IMPLANT THAT HAD WINGS THAT WOULD NOT DEPLOY AND WAS THEREFORE LOOSE IN THE CANAL. THIS WAS DISCOVERED A HAMMERTOE CORRECTION PROCEDURE WITH NO PATIENT HARM REPORTED. A CASE DELAY OF NO MORE THAN 10 MINUTES WAS EXPERIENCED, AND THE CASE WAS COMPLETED USING AN AR-8730-24H COMPRESSION SCREW.