Q-FIX 72290118Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556657447), received between Feb 6, 2018 and Jun 10, 2026 — classified as 6 injuries, 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, THE DISTAL TIP OF THE Q-FIX DRILL BROKE WHILE DRILLING IN THE GLENOID FOSSA AND WAS EMBEDDED IN THE BONE. BROKEN PIECE COULD NOT BE REMOVED FROM THE BODY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25465500 ↗
• InjuryJun 2, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, THE DISTAL TIP OF A Q-FIX DRILL BROKE WHILE DRILLING IN THE GLENOID FOSSA AND WAS EMBEDDED IN THE BONE. BROKEN PIECE COULD NOT BE REMOVED FROM THE BODY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368894 ↗
• InjuryMay 20, 2026Break

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, WHILE A Q-FIX DRILL WAS FULLY SEATED DOWN A Q-FIX DRILL GUIDE XL AND FULL SEATED INTO THE BONE OF THE ACETABULUM, THE DRILL GUIDE SKIVED OFF THE BONE CAUSING THE DISTAL END OF THE DRILL TO BREAK OFF AND BECOME DISLODGED AND BURIED INT THE BONE. THE DISTAL END OF THE DRILL WAS NOT RETRIEVED FORM THE PATIENT SINCE THE SPECIALIST FELT IT WOULD NOT CAUSE HARM TO THE PATIENT BECAUSE IT WAS NOWHERE NEAR THE JOINT SPACE OF THE HIP AND WAS NOT SITTING PROUD OUTSIDE OF THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25230967 ↗
• InjuryDec 23, 2025Break; Break

  IT WAS REPORTED THAT, DURING A BANKART SURGERY, A Q-FIX DRILL'S DISTAL TIP WAS BROKEN OFF AND REMAINED IN THE BONE HOLE WHILE DRILLING. THE PROCEDURE WAS COMPLETED AFTER AN EXTENSION OF FOUR HOURS. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP. AN ADDITIONAL SURGERY WAS PERFORMED AFTER THE BANKART PROCEDURE, WHERE ALL METAL FRAGMENTS WERE REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23882821 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR LABRAL REPAIR, THE Q-FIX FLEXIBLE DRILL BIT BROKE OFF IN THE GLENOID WHILE PLACING THE SECOND POSTERIOR ANCHOR. THE DRILL BIT WAS OPENED NEW BEFORE THE CASE, AND ALL STEPS WERE FOLLOWED CORRECTLY DURING THE PROCEDURE. THE GLENOID AREA WAS PROBED AND VISUALLY INSPECTED AND NOTHING COULD BE SEEN. THE PROCEDURE WAS COMPLETED WITH 2 MINUTES OF SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21542515 ↗
• MalfunctionDec 20, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, AFTER IMPLANTING AND WHILE REMOVING HANDLE A SLIVER OF METAL OF THE Q-FIX DRILL DROPPED OUT. THE PIECE WAS REMOVED FROM THE PATIENT WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20988913 ↗
• MalfunctionNov 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, METAL SHAVINGS WERE COMING OFF FROM THE Q-FIX DRILL. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20715557 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR, THE Q-FIX DRILL WAS PHYSICALLY BROKEN. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937811 ↗
• InjuryDec 28, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE Q-FIX DISPOSABLE FLEXIBLE DRILL BROKE WITHOUT THE SURGEON NOTICING, THEREFORE, THE DRILL BIT DIDN'T BOTTOM OUT AND CAUSED THE Q-FIX SUTURE ANCHOR TO NOT DEPLOY WHEN USED. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064745 ↗
• InjuryJul 27, 2021Break; Break

  IT WAS REPORTED THAT THE DURING HIP ARTHROSCOPY - LABRUM REPAIR, INSIDE THE PATIENT, THE 1.8MM Q-FIX DISPOSABLE FLEXIBLE DRILL BROKE OFF. ALL PIECES WERE REMOVED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235358 ↗
• MalfunctionMar 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, ONE 1.8 MM Q-FIX DRILL BROKE OFF INTO THE GLENOID. IT IS UNKNOWN WHETHER THE FRAGMENTS WERE REMOVED FROM THE PATIENT. IT IS ALSO UNKNOWN HOW THE SURGERY WAS COMPLETED AND IF IT WAS DELAYED. THE PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9826328 ↗
• MalfunctionFeb 6, 2018Break

  IT WAS REPORTED THAT THE DRILL TIP BROKE OFF DURING THE CASE AND WAS LEFT IN THE BONE. IT COULD NOT BE RETRIEVED. NO PATIENT INJURY REPORTED OR SIGNIFICANT TIME DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7245384 ↗