UNK
Received Dec 1, 2025 · Event occurred Nov 6, 2025
Report 1220246-2025-05237 · MDR key 23679319
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Physical Resistance/Sticking
- Physical Resistance/Sticking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, G3, H3, H6 -COMPLAINT ALLEGATION IS CONFIRMED. -VISUAL INSPECTION NOTED THAT AN UNK PIN GOT STUCK/BROKEN INSIDE THE SHAFT AND WAS VISIBLE ON BOTH ENDS OF THE PIN GUIDE, LOCKING. -FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO EXCESSIVE MECHANICAL FORCES DURING PRYING/LEVERAGING AND/OR MISALIGNED INSERTION.
Description of Event or Problem
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0312-200 PIN GUIDE GOT STUCK INSIDE THE INSERTION SLEEVE AND LOCKED UP. THIS WAS DISCOVERED DURING A TROCH NAIL PROCEDURE. THE CASE WAS COMPLETED WITH NO PATIENT HARM.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.