Arthrex® AR-9928BCK-MISRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867389533), received between Aug 5, 2024 and Mar 19, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Positioning Failure

  ON 27-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE 3.9 MM SWIVELOCK ANCHOR FROM AN AR-9928BCK-MIS MIS BIOCOMPOSITE KNOTLESS ACHILLES SPEEDBRIDGE IMPLANT SYSTEM HAD AN EYELET THAT PREMATURELY DISENGAGED FROM THE SWIVELOCK DRIVER AND DID NOT ENTER THE BONE TUNNEL AS EXPECTED AFTER INSERTION. DUE TO LESS-THAN-IDEAL BONE QUALITY, THE SURGEON ELECTED TO USE A LARGER 4.75 MM ANCHOR INSTEAD. THE 4.75 MM ANCHOR FUNCTIONED AS INTENDED, AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 06-MAR-2026: DURING A MIS ACHILLES INSERTIONAL SPEEDBRIDGE PROCEDURE, THE 3.9 MM SWIVELOCK ANCHOR WAS REMOVED AFTER THE ISSUE OCCURRED. THE REMAINING COMPONENTS OF THE KIT WERE USED. THE SURGERY WAS COMPLETED USING AN AR-2324BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. THE PROCEDURE WAS DELAYED BY A FEW MINUTES, AND IT IS UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640844 ↗
• MalfunctionDec 31, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX EMPLOYEE REPORTED VIA EMAIL THAT AN AR-9928BCK-MIS BIOCOMPOSITE KNOTLESS ACHILLES SPEEDBRIDGE IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING USE. AFTER ANCHOR INSERTION, ONE OF THE LINKS FOR THE KNOTLESS FIBERTAKS WAS FOUND TO BE FRAYED, AND THE LINK SUBSEQUENTLY BROKE, PREVENTING THE PASSING OF THE REPAIR SUTURE THROUGH THE ANCHOR. THE SECOND FIBERTAK ANCHOR FUNCTIONED AS INTENDED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. THERE WAS NO HARM TO THE PATIENT, AND THE IMPACT ON THE CASE WAS MINIMAL, RESULTING IN LITTLE TO NO PROCEDURAL DELAY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DEC-2025: THE OCCURRENCE TOOK PLACE DURING A MINIMALLY INVASIVE ACHILLES REPAIR PROCEDURE. THE ORIGINAL FIBERTAK ANCHOR REMAINED IMPLANTED, AND THE SUTURE THAT COULD NOT BE PASSED THROUGH THE ANCHOR WAS TRIMMED FLUSH.

  Patient problems: Foreign Body In Patient

  MAUDE report 23935689 ↗
• MalfunctionApr 17, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 04/14/2025: THE CASE WAS DELAYED 10 MINUTES AS THE SURGEON HAD TO REMOVE THE BROKEN DRILL BIT FROM THE PATIENT. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THE CASE WAS COMPLETED USING A SOLID 2.6 DRILL SINCE THE CANNULATED 2.6 DRILL BROKE. NO ADVERSE EFFECTS OR SIGNIFICANT DAMAGE WAS REPORTED ON OR AFTER THE SURGERY ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859070 ↗
• MalfunctionFeb 21, 2025Break; Break

  ON 02/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE AR-9928BCK-MIS ACHILLES SPEEDBRIDGE BROKE. THIS OCCURRED DURING AN MIS ACHILLES PROCEDURE ON (B)(6) 2025 WHEN THE CANNULATED DRILL BIT BROKE INSIDE THE PATIENT'S CALC. THE FRAGMENTS WERE UNABLE TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED USING AN AR-8929BC-CP. THERE WAS A DELAY OF ABOUT 10 MINUTES AND IT IS UNCERTAIN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21433403 ↗
• MalfunctionSep 11, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE 2.6 MM DRILL BIT FROM AN AR-9928BCK-MIS FIBERTAK ACHILLES SPEEDBRIDGE KIT BROKE WHEN GOING OVER THE WIRE DRILLING FOR THE DISTAL TUNNEL WITH THE RED GUIDE. THE DRILL BIT BROKE INTO MANY FRAGMENTS WHICH WERE ALL SUCCESSFULLY REMOVED. THIS WAS DISCOVERED DURING A MIS ACHILLES PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20193222 ↗
• MalfunctionAug 5, 2024Break; Break

  ON 7/15/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING DRILLING FOR THE PLACEMENT OF A DISTAL INTERFERENCE SCREW, A SMALL FRAGMENT OF THE DRILL BIT WAS NOTICED IN THE CALCANEAL WOUND. THE FRAGMENT WAS VERIFIED BY FLUOROSCOPY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 7/18/2024: THE BROKEN DRILL WAS PART OF AN AR-9928BCK-MIS FIBERTAK ACHILLES SPEEDBRIDGE IMPLANT SYSTEM. THE BROKEN FRAGMENTS WERE NOT REMOVED, AS A RETRIEVAL ATTEMPT WOULD HAVE BEEN MORE PROBLEMATIC. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19905044 ↗