Q-FIX 72290126Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556662649), received between Nov 9, 2020 and Jun 18, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRUM PROCEDURE, THE Q-FIX DRILL BROKE OFF. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TISSUE GRASPERS. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563787 ↗
• MalfunctionMar 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION, WHEN THE BOX OF THE 1.8 Q-FIX DISPOSABLE KIT WAS OPENED, IT WAS FOUND THAT THE SHARP TIP OF THE DRILL GUIDE PENETRATED THROUGH THE PLASTIC COVER, MAKING THE KIT UNSTERILE AND NOT FIT TO BE USED. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18925027 ↗
• InjuryJun 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING A DISTAL BICEPS REPAIR, A QFIX MINI XL KIT DRILL BROKE WHILE DRILLING. IT CAME OUT OF THE BLUE TOP PIECE THAT BOTTOMS OUT; THEN IT GOT LODGED IN THE GUIDE AND CANNOT BE REMOVED. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987076 ↗
• InjuryJun 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING A DISTAL BICEPS REPAIR, A QFIX MINI XL KIT DRILL BROKE WHILE DRILLING. IT SNAPPED IN HALF ON THE METAL, IT GOT LODGED IN THE GUIDE AND CANNOT BE REMOVED. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987072 ↗
• MalfunctionNov 9, 2020Break; Break

  IT WAS REPORTED THAT DURING SHOULDER SURGERY, THE FIRST QFIX MINI SUTURE ANCHOR HAD NO IMPLANT ON THE END AND THE SECOND HAD A BROKEN DRILL. NOTHING FELL INSIDE THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10807362 ↗