Q-FIX 25-2810Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556724651), received between Oct 16, 2020 and Jun 3, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, ONE DRILL BIT FROM THE DISPOSABLE KIT 2.8MM BREAK DURING CHANNEL PREPARATION, ALL THE COMPONENTS WERE REMOVED FROM THE JOINT. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE USED ON THE ORIGINALLY DRILLED BONE HOLE, AND THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129373 ↗
• MalfunctionNov 16, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SHOULDER Q-FIX KIT, WHEN OPENED FROM THE SEALED BOX, HAD HEAT DAMAGE TO THE PACKAGING CAUSING THE PLASTIC TO SHRINK AWAY FROM THE SEAL. IT WAS NOT USED AS IT WAS NOT STERILE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149983 ↗
• InjuryNov 30, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE DRILL OF THE 2.8MM Q-FIX ANCHOR SNAPPED WHEN IT CAME INTO CONTACT WITH THE BONE. THE DRILL WAS REMOVED FROM THE PATIENT WITH FORCEPS. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. PATIENT'S CURRENT STATUS IS HEALTHY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885087 ↗
• InjuryAug 26, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A HIP PROCEDURE USING Q-FIX KIT, THE DRILL SEIZED IN THE DRILL GUIDE. IT WAS NECESSARY TO DRILL AN ADDITIONAL HOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 12368932 ↗
• InjuryMay 10, 2021Break; Break

  IT WAS REPORTED THAT DURING A SLAP REPAIR, THE Q-FIX WENT TO DRILL THE PILOT HOLE AND THE DRILL WENT INTO THE GUIDE AND GOT STUCK IN THE SHAFT OF THE GUIDE, IT WAS REMOVE IT SAFELY OUT OF THE SHOULDER, BUT IT BROKE WHEN TRIED TO DISLODGE THE DRILL/GUIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11800990 ↗
• InjuryOct 16, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A HIP SURGERY, WHEN TRIED TO SLIDE THE DRILL DOWN THE GUIDE, IT GOT STUCK. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10690762 ↗