Arthrex® AR-9929BC-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867389564), received between Jul 1, 2024 and Sep 18, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Positioning Failure; Material Twisted/Bent; Positioning Failure; Material Twisted/Bent

  ON 08/27/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE END OF THE DRIVER FROM AN AR-9929BC-CP 3.9 MM BIOCOMPOSITE ACHILLES PARS/AMSS CC TWISTED AND BROKE OFF INSIDE THE PATIENT, WITH THE SCREW STILL ATTACHED. THE CASE WAS COMPLETED, AND THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THIS WAS DISCOVERED DURING A PARS PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 9/3/2025: THE ISSUE OCCURRED TOWARD THE END OF THE CASE DURING THE FIRST ATTEMPT AT INSERTING A SWIVELOCK ANCHOR. THE IMPLANT FAILED TO DEPLOY. ALL DETACHED FRAGMENTS WERE ACCOUNTED FOR AND RETRIEVED FROM THE PATIENT. TO COMPLETE THE PROCEDURE, A SECOND KIT WAS OPENED, AND THE AR-9929BC-CP SWIVELOCK WAS USED. THE SURGERY WAS DELAYED BY APPROXIMATELY 5¿10 MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 23084445 ↗
• MalfunctionJun 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON 05/13/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN ACHILLES RUPTURE WAS ADDRESSED USING THE AR-9929BC-CP 3.9MM BIOCOMPOSITE ACHILLES PARS IMPLANT SYSTEM. WHILE INSERTING ONE OF THE ANCHORS, THE ANCHOR DRIVER SNAPPED OFF NEAR THE FINAL STAGE OF INSERTION, PRODUCING A NOTICEABLE "POP" SOUND. THE IMPLANT ITSELF REMAINED INTACT AND WAS SUCCESSFULLY UTILIZED FOR THE PATIENT. PLIERS WERE USED TO REMOVE THE BROKEN PORTION OF THE DRIVER BODY FROM THE IMPLANT POST-INSERTION TO RESOLVE THE ISSUE. DESPITE THIS UNEXPECTED OCCURRENCE, THE SURGEON CONFIRMED THAT THE ANCHOR'S TRAJECTORY ALIGNED CORRECTLY WITH THE DRILL TUNNEL AND THAT ALL STEPS WERE PERFORMED AS INTENDED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 06/03/2025.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161413 ↗
• MalfunctionApr 21, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/22/2025: MINIMAL ACHILLES DEBRIDEMENT WAS PERFORMED, AND A RONGEUR WAS USED FOR EXTRACTION. NO ADDITIONAL INCISIONS WERE NECESSARY. THE CASE WAS COMPLETED USING SOLID DRILL BIT DRILLING, WITH NO CHANGES TO THE SURGICAL TECHNIQUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21874874 ↗
• MalfunctionMar 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SECOND 3.9 SWIVELOCK FROM AN AR-9929BC-CP 3.9MM BIOCOMPOSITE ACHILLES PARS IMPLANT SYSTEM BROKE. THE FIRST SWIVELOCK AND SUTURETAPES WERE IMPLANTED WITHOUT ISSUES. WHEN THE SECOND SWIVELOCK WAS ATTEMPTED TO BE IMPLANTED, IT BROKE. ANOTHER AR-9929BC-CP 3.9MM BIOCOMPOSITE ACHILLES PARS IMPLANT SYSTEM WAS OPENED AND THE 3.9MM SWIVELOCK FROM THAT KIT DID NOT STAY IMPLANTED; IT PULLED OUT DUE TO THE FIRST SWIVELOCKS ANCHOR DISRUPTING THE DRILL HOLE. AN AR-8929BC-CP ACHILLES MID SUBSTANCE SPEEDBRIDGE IMPLANT SYSTEM WAS OPENED AND THE 4.75 SWIVELOCK WAS USED WITH THE SUTURETAPES FROM THE ACHILLES REPAIR TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACHILLES MIDSUBSTANCE REPAIR PROCEDURE ON (B)(6)2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664364 ↗
• MalfunctionMar 21, 2025Break; Break

  ON 3/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SECOND 3.9 SWIVELOCK FROM AN AR-9929BC-CP 3.9MM BIOCOMPOSITE ACHILLES PARS IMPLANT SYSTEM BROKE. THE FIRST SWIVELOCK AND SUTURETAPES WERE IMPLANTED WITHOUT ISSUES. WHEN THE SECOND SWIVELOCK WAS ATTEMPTED TO BE IMPLANTED, IT BROKE. ANOTHER AR-9929BC-CP 3.9MM BIOCOMPOSITE ACHILLES PARS IMPLANT SYSTEM WAS OPENED AND THE 3.9MM SWIVELOCK FROM THAT KIT DID NOT STAY IMPLANTED; IT PULLED OUT DUE TO THE FIRST SWIVELOCKS ANCHOR DISRUPTING THE DRILL HOLE. AN AR-8929BC-CP ACHILLES MID SUBSTANCE SPEEDBRIDGE IMPLANT SYSTEM WAS OPENED AND THE 4.75 SWIVELOCK WAS USED WITH THE SUTURETAPES FROM THE ACHILLES REPAIR TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACHILLES MIDSUBSTANCE REPAIR PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664294 ↗
• MalfunctionJan 2, 2025Break; Break

  ON 12/5/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE TIP OF THE DRILL BIT FROM AN AR-9929BC-CP BIOCOMPOSITE ACHILLES PARS KIT BROKE OFF INTO A FEW PIECES INSIDE THE PATIENT'S HEELBONE. THE SURGEON EXTRACTED THE PIECES MANUALLY USING THE AVAILABLE SURGICAL INSTRUMENTS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/12/2024: DURING THE DRILLING PROCESS ON THE LATERAL ASPECT OF THE CALCANEUS, THE DRILL BIT BROKE. THE K WIRE WAS REMOVED, AND ALL PORTIONS OF THE DRILL BIT WERE REMOVED, WITH CONFIRMATION ON INTRAOPERATIVE FLUOROSCOPY. THIS WAS DISCOVERED DURING AN ACHILLES TENDON REPAIR WITH ARTHREX PARS WITH A SUTURE BRIDGE.

  Patient problems: Insufficient Information

  MAUDE report 21061306 ↗
• MalfunctionOct 3, 2024Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION RECEIVED ON 10/1/2024: THE METAL SHAVINGS WERE NOTICED ON THE FINAL X-RAY DURING THE ACHILLES SPEEDBRIDGE PROCEDURE. THE DEBRIS WAS NOT REMOVED, AND ALL THE IMPLANTS IN THE KIT WERE USED IN THE PROCEDURE. AT THIS TIME, THERE IS NO PLAN FOR A REVISION SURGERY. THE CASE WAS COMPLETED IN A NORMAL FASHION, WITH NO DELAYED, AND NO ADDITIONAL ANESTHESIA WAS NEEDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20359943 ↗
• MalfunctionJul 2, 2024Break; Break

  ON 6/6/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE CANNULATED DRILL FROM AN AR-9929BC-CP BROKE OFF INTO THE BONE AFTER HITTING A POSITIVE STOP WITH THE GUIDE. REMOVING THE DRILL AND BROKEN FRAGMENT TOOK ABOUT TEN MINUTES. THE IMPLANTS FROM THE KITS WERE IMPLANTED SUCCESSFULLY. THIS WAS DISCOVERED DURING AN ACHILLES RUPTURE PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 6/10/2024: THE CASE WAS COMPLETED USING THE IMPLANTS FROM THE SAME KIT. THE CASE WAS DELAYED BETWEEN TEN TO FIFTEEN MINUTES. ADDITIONAL ANESTHESIA WAS NOT NECESSARY. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659131 ↗
• MalfunctionJul 1, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ON 06/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9929BC-CP 3.9MM BC ACHILLES PARS/ AMSS CC DRILL ENDED UP BREAKING OFF. THIS OCCURRED DURING AN ACHILLES REPAIR USING THE PARS AND MIDSTUBSTANCE KIT. THEY INSERTED THE GUIDEWIRE TO DRILL WITH OUR 2.6 CANNULATED DRILL AT A 45-DEGREE ANGLE IN THE DRILL. THE PATIENT'S BONE WAS SO HARD THAT THE DRILL ENDED UP BREAKING OFF INTO THE PATIENT'S BONE. THEY WERE NOT AWARE OF THIS UNTIL THEY TRIED TO INSERT THE ANCHOR, AND THE INSERTER BENT BECAUSE DRILL SHAVINGS WERE STOPPING THE ANCHOR FROM ENTERING. ANOTHER KIT WAS OPENED BECAUSE THEY NEEDED A NEW 3.9 SWIVELOCK. THE SURGEON DECIDED TO DRILL AGAIN USING THE SOLID 2.6 DRILL IN A DIFFERENT HOLE. THE CASE WAS COMPLETED AS PER USUAL AND THE REPAIR WAS FINISHED. BEFORE THE SKIN WAS CLOSED, THE SURGEON TOOK X-RAYS TO SEE IF THEY COULD GET THE REMAINDER OF THE DRILL OUT OF THE PATIENT. THE X-RAY SHOWED THAT IT WAS LODGED INSIDE THE CALCANEUS. THE SURGEON DECIDED IT WOULD BE BETTER TO LEAVE THE DRILL PIECE INSIDE OF THE PATIENT INSTEAD OF MAKING A LARGER INCISION AND REMOVING PART OF HIS BONE TO FIND THIS PIECE. THE INCISIONS WERE CLOSED, AND JUMPSTART DRESSING WAS PLACED

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19645912 ↗