Arthrex® AR-3750SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867434769), received between Jan 12, 2024 and Feb 16, 2026 — classified as 4 malfunctions.

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

• MalfunctionFeb 16, 2026Device Dislodged or Dislocated

  ON 28-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3750SP KNEE FIBERTAK ANCHOR FOR THE INTERNALBRACE AND AN AR-3780SP KNEE FIBERTAK BUTTON BOTH PULLED OUT OF THE BONE AND DID NOT ACHIEVE FIXATION. BOTH DEVICES WERE REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT AR-3750SP KNEE FIBERTAK ANCHOR AND AN AR-1593-P SECONDARY FIXATION WITH PEEK SWIVELOCK ANCHOR IMPLANT SYSTEM. NO SURGICAL DELAY OR ADDITIONAL ANESTHESIA WAS REQUIRED. THIS EVENT OCCURRED DURING A DISTAL MCL PROCEDURE PERFORMED ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344822 ↗
• MalfunctionJan 14, 2026Break

  ON 23-DEC-2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT FOLLOWING COMPLETION OF AN MPFL INTERNAL BRACE PROCEDURE, A POSTOPERATIVE X-RAY REVEALED WHAT APPEARED TO BE THE SHAFT OF THE FIBERTAK FROM AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK ANCHOR. A THOROUGH SEARCH WAS CONDUCTED, BUT THE COMPONENT WAS NOT LOCATED OUTSIDE THE PATIENT. IT WAS DETERMINED THAT THE FRAGMENT REMAINED WITHIN THE BONE TUNNEL, AND THE WOUND WAS RECLOSED. THE ANCHOR REMAINED FUNCTIONAL AND WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. THE EVENT RESULTED IN A SURGICAL DELAY OF OVER ONE HOUR, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE BROKEN PIECE REMAINS IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 05-JAN-2025: NO ADDITIONAL SURGERY IS PLANNED TO RETRIEVE THE PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24066634 ↗
• MalfunctionSep 6, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3750SP KNEE FIBERTAK WAS NOT ADVANCING AND THE INSERTER ENDED UP BENT WITH A BROKEN FRAGMENT. THE BONE SOCKET WAS DRILLED, AND THE SURGEON USED A MALLET TO IMPACT THE ANCHOR. THE ANCHOR WAS NOT ADVANCING GREAT, BUT THE INSERTER WAS BENT WHEN IT WAS DOWN TO THE HUB AND PULLED BACK. THE TIE THAT WAS HOLDING THE IMPLANT SNAPPED OFF, AND THE IMPLANT DID NOT HOLD. THE INSERTER HAD A BROKEN PIECE, BUT THE SURGEON DECIDED NOT TO PERFORM AN X-RAY. THE SURGEON WAS CONFIDENT THE PIECE OF INSERTER WAS EITHER EMBEDDED IN THE PATIENT'S BONE OR OUTSIDE OF THE PATIENT. EVERYTHING ELSE WAS REMOVED FROM THE PATIENT, AND ANOTHER AR-3750SP KNEE FIBERTAK WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ANTEROLATERAL LIGAMENT REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED LESS THAN FIFTEEN MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 20156772 ↗
• MalfunctionJan 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06433587 THAT AN AR-3750SP KNEE FIBERTAK PULLED OUT. THIS WAS DISCOVERED DURING A PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 12/21/2023: THIS WAS DISCOVERED DURING AN ACLR WITH AN MCL REPAIR PROCEDURE ON 12/13/2023. THE CASE WAS COMPLETED USING AN AR-2324BCC BIOCOMPOSITE SWIVELOCK C, AND NOTHING BROKE INSIDE THE PATIENT. THE CASE WAS ONLY DELAYED FOR A MINUTE OR TWO, AND ADDITIONAL ANESTHESIA WAS UNNECESSARY. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502036 ↗