Arthrex® AR-8941-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867051713), received between Sep 4, 2019 and Sep 4, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2019Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE RECEIVING CLERK AT THE FACILITY HAD SUSTAINED A HAND PENETRATION INJURY FROM THE PRODUCT THAT HAD PUNCTURED THE SKIN AND CAUSED BLEEDING. THE AR-8941-12 (GUIDE WIRE, LONG), WHICH IS SOLD IN A SEALED PLASTIC POUCH, WAS SHIPPED TO THE FACILITY IN A CARTON WHICH CONTAINED ADDITIONAL PRODUCTS PURCHASED. THE GUIDE WIRE HAD PENETRATED THROUGH ITS PLASTIC POUCH AND THE CARDBOARD SHIPPING BOX. THE RECEIVING CLERK DID NOT NOTICE THE GUIDEWIRE STICKING OUT OF THE BOX UNTIL THE CLERK MOVED THE CARTON AT WHICH TIME THE GUIDEWIRE PUNCTURED THE CLERK¿S SKIN. THERE WAS NO SURGICAL CASE INVOLVEMENT. ARTHREX HAS BEEN PROVIDED PICTURES OF THE PUNCTURE WOUND, SHIPPING BOX AND DEVICE PACKAGING. ADDITIONAL INFORMATION PROVIDED 8/29/2019: THE RECEIVING CLERK RECEIVED THE CUT ON HIS LEFT MIDDLE FINGER. SHORTLY AFTER THE INCIDENT, THE SMALL INJURY WAS CLEANED AND A BAND-AID WAS PLACED OVER IT TO STOP THE BLEEDING. THERE WAS NO MEDICAL ATTENTION REQUIRED AND HE DID NOT HAVE TO MISS ANY TIME FROM WORK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 8960718 ↗