Arthrex® AR-9928BCK-DXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867425736), received between Mar 26, 2024 and Apr 17, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 03/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9928BCK-DX ACHILLES SPEEDBRIDGE FIBERTAPE WAS NOT SWEDGED TOGETHER AND A SWIVELLOCK EYELET AND SUTURES CAME OUT WHEN INSERTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE WAS COMPLETED USING ANOTHER SWIVELLOCK. DELAY IN CASE WAS 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859733 ↗
• MalfunctionJan 3, 2025Break; Crack; Break; Crack

  ADDITIONAL INFORMATION WAS RECEIVED ON 01/02/2025: THE CRACKED ANCHOR WAS RETRIEVED AND THEN RE-INSERTED INTO THE PATIENT. HOWEVER, THE ANCHOR WAS SLIGHTLY DAMAGED AND HAD TO BE TRIMMED OFF BY A FEW MILLIMETERS AT THE TOP LAYER OF THE BONE TO ENSURE IT WAS FLUSH. THE ANCHOR WAS FLUSH AT THE END OF THE REPAIR. NO REVISION SURGERY WAS NEEDED, AND NO CASE DELAY WAS REPORTED. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED. THIS WAS DISCOVERED DURING A HAGLUNDS BONE SPUR REMOVAL AND ACHILLES REPAIR ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21070738 ↗
• MalfunctionApr 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SOLIDER REPAIR STITCH OF ONE OF THE FIBERTAK FROM AN AR-9928BCK-DX BIOCOMPOSITE ACHILLES SPEEDBRIDGE IMPLANT SYSTEM PULLED OUT OF THE ANCHOR. THE SURGEON INSERTED THE PROXIMOLATERAL KNOTLESS FIBERTAK, AND WHEN THE SOLID REPAIR STITCH WAS PULLED, THE STITCH PULLED OUT OF THE ANCHOR ALONG WITH THE KNOTLESS MECHANISM. THE CASE WAS COMPLETED USING THE EXISTING ANCHOR¿S TAPES AND MAKING A TRADITIONAL SPEEDBRIDGE. THE KNOTLESS RIPSTOP WAS NOT COMPLETED BECAUSE THERE WAS NO REPAIR STITCH OR KNOTLESS MECHANISM IN THE FAULTY ANCHOR AFTER IT PULLED OUT. THE CASE WAS DELAYED ABOUT FIVE MINUTES. THIS WAS DISCOVERED DURING AN ACHILLES SPEEDBRIDGE PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19096771 ↗
• MalfunctionMar 26, 2024Defective Device; Defective Device

  ON 3/8/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9928BCK-DX ACHILLES SPEEDBRIDGE REPAIR IMPLANT SYSTEM HAD AN ISSUE DURING AN ACHILLES REPAIR PROCEDURE ON (B)(6) 2024. THE FIBERTAK IN THAT SYSTEM SHOULD ONLY HAVE ONE LOOP PER ANCHOR, BUT ONE OF THE TWO FIBERTAK DEVICES HAD TWO LOOPS INSTEAD AND COULD NOT BE USED. THIS WAS DISCOVERED UPON INSERTION INTO THE PATIENT, AND THE TECHNIQUE COULD NOT BE DONE CORRECTLY DUE TO THE DOUBLE-LOOPED SUTURE. THE SUTURES OF THE COMPLAINT DEVICE WERE THEN CUT AND REMOVED, AND THE ANCHOR REMAINED INSIDE THE PATIENT. NOTHING BROKE INSIDE THE PATIENT. THE RIPSTOP OF THE PROCEDURE WAS ELIMINATED. THE OTHER FIBERTAK WAS USED WITHOUT ANY ISSUES. BOTH ANCHORS WERE LEFT INSIDE THE PATIENT, AND THE SPEED BRIDGE PART OF THE PROCEDURE WAS COMPLETED, BUT NOT THE RIPSTOP PART. THE ACHILLES REPAIR PROCEDURE WAS STILL COMPLETED SUCCESSFULLY, BUT NOT ACCORDING TO THE TECHNIQUE GUIDE. THE SURGEON DEEMED EVERYTHING TO BE AFFIXED CORRECTLY, AND THERE WAS NO HARM OR ADVERSE EFFECT ON THE PATIENT. A CASE DELAY OF 90 MINUTES WAS REPORTED, AND IT COULD NOT BE CONFIRMED WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NO PICTURES OR

  Patient problems: Foreign Body In Patient

  MAUDE report 18980996 ↗