Hip Instruments 01.10.10.130Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630040742115), received between Mar 20, 2019 and Oct 11, 2019 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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.

• InjuryOct 11, 2019Break; Break

  THE INSTRUMENT BALL AND SPRING MECHANISM POPPED OUT DURING SURGERY. NO PATIENT/USER HARM, THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178080 ↗
• MalfunctionSep 25, 2019Break; Break

  DURING SURGERY IT WAS NOTICED THAT THE SPRING OF THE LEVER ARM OF THE BROACH HANDLE WAS BROKEN. THE BALL AND THE SPRING DIDN'T FALL INTO THE PATIENT. THE SURGEON SWITCHED WITHOUT DELAY TO THE SECOND HANDLE THAT WAS IN THE SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9115639 ↗
• MalfunctionJul 26, 2019Fracture; Fracture

  DURING SURGERY THE LOCKING BALL FELL OUT OF THE HANDLE. THE BALL IS NOT FALLING IN THE PATIENT. THE SURGERY HAS BEEN COMPLETED USING ANOTHER INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830086 ↗
• MalfunctionJul 23, 2019Break; Break

  DURING THE SURGERY THE INSTRUMENT LEVER LOCKING BALL FELL OUT OF THE INSTRUMENT. IT DIDN'T FELL IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A BACK-UP HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8816678 ↗
• MalfunctionMay 28, 2019Break; Break

  AFTER SURGERY IT WAS FOUND THAT THE SPRING AND BALL OF THE LEVER BLOCK MECHANISM WERE MISSING. NO PIECE REMAINED THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8645821 ↗
• MalfunctionMay 17, 2019Break; Break

  DURING A SURGERY THE LOCKING BALL OF THE INSTRUMENT FELL OUT OF THE HANDLE. THE BALL DID NOT FALL IN THE PATIENT. THE STRAIGHT AMIS-BROACH HANDLE HAS BEEN USED TO COMPLETE THE SURGERY SUCCESSFULLY, NO CRITICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619673 ↗
• MalfunctionApr 18, 2019Break; Break

  DURING SURGERY THE INSTRUMENT LOCKING BALL FELL OUT OF THE HANDLE. THE BALL DID NOT FALL IN THE PATIENT. STRAIGHT BROACH HANDLE USED TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8527547 ↗
• MalfunctionApr 3, 2019Break; Break

  DURING SURGERY, THE LOCKING BALL FELL OUT FROM THE HANDLE. THE SURGEON USED A STRAIGHT BROACH HANDLE TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8478384 ↗
• MalfunctionMar 21, 2019Break; Break

  DURING THE SURGERY THE BROACH HANDLE BALL SPRING FELL OUT OF ITS SIEGE. IT DID NOT FALL IN THE PATIENT. THE SURGEON USED THE STRAIGHT BROACH HANDLE TO COMPLETE THE SURGERY SUCCESSFULLY, NO CRITICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8439895 ↗
• MalfunctionMar 20, 2019Break; Break

  DURING SURGERY THE LOCKING BALL FELL OUT OF THE HANDLE WHILE A NURSE WANTED TO REMOVE THE BROACH FROM THE HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8436667 ↗