NA 03.111.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982072115), received between Dec 13, 2016 and Sep 13, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, ATTACHMENTS WERE GETTING STUCK IN THE HANDLE AND WOULD NOT COME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH UNKNOWN MINUTES OF SURGICAL DELAY REPORTED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459532 ↗
• MalfunctionSep 3, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, THE SURGEON WAS USING THE BONE HARVESTING INSTRUMENT SET TO COLLECT ILIAC BONE GRAFT. HE USED A MALLET TO HIT THE END OF THE HANDLE IN ORDER TO GET THE TREPHINE TO SINK INTO THE BONE. WHEN SURGEON TRIED TO PULL THE HANDLE, THE TREPHINE STAYED IN THE BONE AND THE DISTAL END OF THE SHAFT FOR THE TREPHINES BROKE OFF. THE PIN ON THE QUICK CONNECT RELEASE PORTION OF THE HANDLE BROKE OFF AS WELL. THE DISTAL END OF THE SHAFT FOR THE TREPHINES BROKE OFF. THERE WAS NO SURGICAL DELAY NOTED. FRAGMENTS GENERATED WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - MALLET (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SILICONE HANDLE QUICK COUPLING/LONG. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422660 ↗
• MalfunctionAug 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, DURING THE SURGERY THE QUICK CONNECT HANDLE LATCHES ON QUICK CONNECT INSTRUMENT AND WILL NOT RELEASE. THE INSTRUMENTS GET STUCK DOWN IN THE CONNECTION PORTION TO THE HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) SILICONE HANDLE QUICK COUPLING/LONG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366477 ↗
• MalfunctionMar 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, UPON ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT TRAY IT WAS NOTICED THAT THE SILICONE HANDLE QUICK COUPLING DOES NOT ENGAGE WITH ANY OF THE ITEMS THAT ARE ATTACHED TO IT. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SILICONE HANDLE QUICK COUPLING/LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582201 ↗
• MalfunctionDec 13, 2016Break; Break

  IT WAS REPORTED THAT DURING INSPECTION AT THE METRO OFFICE IT WAS NOTICED THE SILICONE HANDLE QUICK COUPLING/LONG WOULD NO LONGER LOCK INTO PLACE PROPERLY. THERE WAS NO SURGERY OR PATIENT INVOLVEMENT. DURING THE MANUFACTURER INVESTIGATION PROCESS IT WAS IDENTIFIED THAT THE RETURNED SILICONE HANDLE QUICK COUPLING/LONG IS BROKEN IN TWO PIECES. THE NOSEPIECE/COUPLING IS SEPARATE FROM THE REMAINDER OF THE DEVICE. THE PIN THAT SECURES THE COUPLING TO THE DEVICE HAS SHEARED OFF AND A PORTION OF THE PIN REMAINS IN THE DEVICE AND A PORTION OF THE PIN IS NO LONGER PRESENT. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON DECEMBER 9, 2016. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6169920 ↗