NA 03.207.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982075987), received between Aug 29, 2019 and Aug 29, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• InjuryAug 29, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SLIPPED CAPITAL FEMORAL EPIPHYSIS (SCFE) PROCEDURE ON AN UNKNOWN DATE, THE SURGEON ENCOUNTERED AN ISSUE WITH THE DRILL BIT WHERE IT WAS BINDING AND PUSHING ON THE GUIDE WIRE ALONG WITH THE DRILL BIT. THE LEFT HIP WAS DONE FIRST. THE SURGEON REPORTED THAT THE GUIDEWIRE PUSHED THE FEMORAL HEAD AND INTO THE ACETABULAR AREA; ALTHOUGH, IT WAS NOT SURE IF THE ACETABULUM WAS COMPLETELY PENETRATED. IT WAS MENTIONED THAT THE SAME DRILL BIT WAS PROBLEMATIC ON THE CONTRA LATERAL SIDE; THE SURGEON HAD TO BE EXTRA CAREFUL TO ENSURE THAT THE SAME ISSUE WOULD NOT OCCUR. IT WAS NOTED THAT DURING THE PROCEDURE FOUR (4) GUIDE WIRES BENT; HOWEVER ONLY ONE OF THE WIRES PENETRATED THE ACETABULUM ON THE RIGHT HIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED DESPITE THE DRILL BIT ISSUE. THERE WAS A THIRTY TO FORTY-FIVE (30-45) MINUTE SURGICAL DELAY REPORTED. CONCOMITANT DEVICE REPORTED: SCFE SCREW (PART 02.207.626, LOT UNKNOWN, QUANTITY 1), SCFE SCREW (PART 02.207.625, LOT UNKNOWN, QUANTITY 1), OVAL WASHER (PART 02.207.637, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 8944773 ↗