Hip Instruments 01.10.10.131Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630040742122), received between Feb 28, 2019 and Apr 7, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE SAME SURGERY THE BROACHES HANDLES DISASSEMBLED WHILE THE SURGEON WAS SWITCHING FROM A BROACH TO THE NEXT ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY USING EXTRA STRAIGHT BROACH HANDLES, BUT THERE WERE 40 MINUTES OF DELAY DUE TO THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11626168 ↗
• MalfunctionAug 30, 2019Material Fragmentation; Material Fragmentation

  THE BALL AND THE SPRING OF THE LEVER FROM THE OFFSET BROACH HANDLE WAS FALLING IN THE PATIENT DURING THE SURGERY. THE PART ARE REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8949450 ↗
• MalfunctionAug 22, 2019Break; Break

  BALL BEARING MECHANISM BREAKAGE DURING SURGERY. THE BALL DID NOT FALL INTO THE PATIENT. A STRAIGHT BROACH HANDLE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8921003 ↗
• MalfunctionJun 14, 2019Material Fragmentation; Material Fragmentation

  THE LOCKING BALL OF THE INSTRUMENT LEVER FELL OUT FROM THE HANDLE. NO PIECE FELL INTO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8699598 ↗
• MalfunctionApr 26, 2019Break; Break

  DURING THE IMPACTION THE INSTRUMENT BALL SPRING FELL OUT THE PASSING HOLE AND THE SPRING WAS BROKEN. THE BALL DID NOT FALL IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A STRAIGHT BROACH HANDLE. THE SAME DAY THE SURGEON HAD A SECOND IDENTIC CASE WITH A SECOND BROACH HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8555124 ↗
• MalfunctionMar 21, 2019Break; Break

  DURING THE SURGERY THE LOCKING BALL FELL OUT OF THE HANDLE. THE BALL IS NOT FALLING IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8439896 ↗
• MalfunctionMar 18, 2019Break; Break

  THE LOCKING BALL FELL OUT OF THE HANDLE. A STRAIGHT BROACH HANDLE (REF. 01.15.10.0131) WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428910 ↗
• MalfunctionMar 1, 2019Device Fell

  DURING THE INSTRUMENT IMPACTION THE LOCKING BALL AND THE SPRING FALL OUT THE PASSING HOLE. THE BALL DIDN'T FALL IN THE PATIENT. THE SURGEON FINISHED THE IMPACTION WITH THE SAME HANDLE WHILE HE HOLDS THE LEVER WITH HIS HAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8381775 ↗
• MalfunctionFeb 28, 2019Break; Break

  DURING THE IMPACTION THE BALL OF THE BROACH HANDLE FELL OUT FROM THE PASSING HOLE AND THE SPRING WAS BROKEN, NO DEBRIS FELL IN THE PATIENT. THERE WAS A DELAY OF MAX. FIVE MINUTES.

  Patient problems: No Code Available

  MAUDE report 8377334 ↗
• MalfunctionFeb 28, 2019Break; Break

  DURING SURGERY THE LOCKING BALL AND THE SPRING FELL OUT OF THE HANDLE WHILE A NURSE WANTED TO REMOVE THE BROACH FROM THE HANDLE. THERE WAS A DELAY OF MAX. FIVE MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377333 ↗