NA 03.211.425Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982076342), received between Sep 17, 2018 and Sep 17, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 17, 2018Break; Break

  IT WAS REPORTED THAT DURING A METATARSAL-PHALANGEAL JOINT (MTP) ARTHRODESIS ON (B)(6) 2018, ONE (1) OUT OF THREE (3) COMPRESSION WIRES SNAPPED ABOVE ITS BALL TIP UPON INSERTION, LEAVING ITS DISTAL THREADED PORTION AND BALL TIP ATTACHED, AND STILL IMPLANTED IN THE PATIENT. A STANDARD UNKNOWN WIRE DRIVER WAS USED TO INSERT THE WIRE. USING UNKNOWN PLIERS AROUND THE BALL COMPONENT OF THE IMPLANTED WIRE PORTION, THE SURGEON ATTEMPTED TO UNSCREW THE WIRE. THE BALL COMPONENT SNAPPED FROM THE THREADED PORTION OF THE WIRE, LEAVING ONLY THE THREADED PORTION IMPLANTED IN THE PATIENT. THE WIRE HAS A TROCAR TIP. THERE WERE NO TOOLS AVAILABLE TO REMOVE THE WIRE AND NO ADEQUATE REMOVAL TOOLS OWNED BY THE HOSPITAL. SURGEON USED A SMALL HOLLOW REAMER AND UNKNOWN EXTRACTION PIECE FROM A SCREW REMOVAL SET TO REMOVE THE WIRE. REMOVAL WAS SUCCESSFUL AND THERE WERE NO APPARENT DETRIMENTAL OUTCOMES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 30-45 MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE EVENT TO PATIENT AND THE PATIENT'S CONDITION WAS STABLE POST SURGERY. CONCOMITANT DEVICES REPORTED: PLIERS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), WIRE DRIVER (PART NUMBER UNKNOWN, LOT NUMBER UNKNO

  Patient problems: No Code Available

  MAUDE report 7883196 ↗