NA 03.037.104Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982070531), received between May 1, 2019 and Oct 27, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE LOCKING PIN BROKE ON CENTERING SLEEVE OF HOLLOW REAMER. THIS WAS DISCOVERED WHEN THE SET WAS OPENED FOR A CASE. THE HOLLOW REAMER WAS USED WITHOUT THE CENTERING SLEEVE WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: SLEEVE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 16MM CANN PERCUTANEOUS HOLLOW DRILL BIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10742165 ↗
• MalfunctionMay 2, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PIN FROM THE CENTERING SLEEVE WAS BROKEN ON THE HOLLOW REAMER LONG CANNULATED WHEN THE SET WAS OPENED TO BE USED FOR SURGERY ON (B)(6) 2019. THE INSTRUMENT WAS UNUSABLE, AN ALTERNATIVE INSTRUMENT WAS USED WHICH WAS APPROPRIATE FOR THE SURGERY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 16MM CAN PERCUTANEOUS HOLLOW DRILL BIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573681 ↗
• MalfunctionMay 1, 2019Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THE CENTERING PIECE OF THE TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) CANNULATED PERCUTANEOUS HOLLOW DRILL BIT WAS NOT CLICKING INTO OUTER PIECE. IT APPEARS THE SPRING ON THE CENTERING PIECE IS NOT PRESENT. THIS WAS DISCOVERED PREOPERATIVELY WHILE THE OPERATING ROOM (OR) TEAM WERE SETTING UP FOR THE CASE. IT WAS UNKNOWN WHEN THE SPRING BROKE FROM THE CENTERING PIECE. AN ALTERNATIVE ON THE SAME INSTRUMENT SET WAS USED SO THERE WAS NO DELAY TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PERCUTANEOUS HOLLOW DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8570491 ↗