Arthrex® AR-1593-BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867331310), received between Jun 21, 2021 and Jul 27, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Patient Device Interaction Problem

  It was reported by a patient, through review of medical records, that on (b)(6) 2025, the patient underwent ACL reconstruction. The operative report indicates the following Arthrex products were used for the procedure: AR-4580R FiberStitch (Lot Unknown), AR-4580S FiberStitch (Lot 25C05) AR-1588AL-CP2 Allograft GraftLink Implant System (Lot 15317362); AR-4580 FiberStitch (Lot 25D03), AR-4020-C-09 FastThread BioComposite Interference Screw, 9 x 20 mm (Lot 15454391) and AR-4020C-09 and AR-4020P-10 FastThread PEEK Interference Screw 10 mm × 20 mm (Lot 15231522A). Patient medical records support implantation of the AR-4020C-09 and AR-4020P-10 interference screws. Information provided by the patient alleges an AR-4030C-10 BioComposite Interference Screw, 10 x 30 mm may have been used and fractured during implantation; however, no such event is documented in the November 24, 2025 operative report. The exact intraoperative sequence, device utilization, and circumstances surrounding the alleged fracture of a device could not be conclusively determined from the available records. Following a reported traumatic event at home where the patient's left knee was hyperextended and twisted, the pat

  Patient problems: Failure of Implant

  MAUDE report 50006451 ↗
• MalfunctionSep 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 9/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SWIVELOCK ANCHOR FROM AN AR-1593-BC SECONDARY FIXATION IMPLANT SYSTEM PULLED OUT OF THE MEDIAL CONDYLE. THIS WAS DISCOVERED DURING AN MCL PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING A 5.5 MM SWIVELOCK. ADDITIONAL INFORMATION RECEIVED ON 9/23/2024: THE CASE WAS DELAYED ABOUT AN HOUR, AND ADDITIONAL ANESTHESIA WAS USED. THE CASE WAS COMPLETED USING AN AR-7221 FIBERWIRE.

  Patient problems: Insufficient Information

  MAUDE report 20292840 ↗
• MalfunctionMay 14, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE HANDLE DISENGAGED FROM THE TAP DURING USE. THEY USED ANOTHER TAP TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19311899 ↗
• InjuryJan 11, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED ON 1/17/2024: THE PATIENT STARTED TO EXPERIENCE SYMPTOMS ABOUT TWELVE TO SIXTEEN MONTHS AFTER THE PROCEDURE WAS PERFORMED. CULTURES WERE TAKEN FROM THE INFECTION SITE, AND DESPITE THE INTENSIVE REVIEW FROM THE INFECTIOUS DISEASE PHYSICIAN, THE RESULTS CAME BACK NEGATIVE. THE PATIENT HAS UNDERGONE TWO INCISIONS AND DRAINAGE PROCEDURES DUE TO THE RECURRING INFECTIONS. THE PATIENT IS CURRENTLY STILL BEING TREATED FOR INFECTIONS AND DRAINAGE. THE LOT NUMBER FOR THE AR-1593-BC BIOCOMPOSITE SWIVELOCK IMPLANT SYSTEM REMAINS UNKNOWN. AT THIS TIME, NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Abscess

  MAUDE report 18496127 ↗
• MalfunctionJul 21, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 6/23/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE INSERTER HANDLE OF A SWIVELOCK FROM AN AR-1593-BC SECONDARY FIXATION IMPLANT SYSTEM WAS PRESSED AGAINST THE ANCHOR, AND IT COULD NOT BE IMPLANTED. ADDITIONAL INFORMATION RECEIVED ON 6/23/2023: THIS WAS DISCOVERED DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2023. NOTHING BROKE INSIDE THE PATIENT AS THE ANCHOR REMAINED INTACT. THE CASE WAS COMPLETED USING AN INDIVIDUAL AR-2324BCC SWIVELOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371955 ↗
• MalfunctionMay 26, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1593-BC SWIVELOCK DRIVER BEGAN TO TWIST AROUND PROXIMAL PORTION OF ANCHOR AND WOULD NOT SEAT ANCHOR, ANCHOR DID FRACTURE. THIS WAS DISCOVERED DURING A CASE , DEVICE BREAKS DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 17011893 ↗
• MalfunctionNov 28, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1593-BC SWIVELOCK IMPLANT SYSTEM BROKE. THIS OCCURRED DURING AN ACL RECONSTRUCTION WHEN THE IMPLANT WAS IMPLANTED PER SURGICAL TECHNIQUE THE IMPLANT BROKE HALF WAY INTO THE PATIENT, HALF OF THE IMPLANT REMAINS IN THE PATIENT, AND THE OTHER HALF WAS DISCARDED. NOTHING FURTHER WAS NEEDED TO COMPLETE THE PROCEDURE. THE PATIENT HAD HARD BONE, WHICH WAS PREPPED USING A DRILL, AND A LARGE TAP. THERE WAS NO PATIENT EFFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15873370 ↗
• MalfunctionOct 10, 2022Break; Positioning Problem

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1593-BC SWIVELOCK ANCHOR MUSHROOMED AND BROKE ON INSERTION. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15569607 ↗
• MalfunctionJul 6, 2021Break; Entrapment of Device

  IT WAS REPORTED DURING AN ACL RECONSTRUCTION WITH AN INTERNAL BRACE THE ANCHOR BROKE ON INSERTION. THE IMPLANT WAS RETRIEVED BUT THE EYELET WAS NOT. IT WAS REPLACED WITH A PEEK SWIVEL LOCK AR-2324PSLC AND THE VERY SAME EVENT OCCURRED. ONCE AGAIN THE IMPLANT WAS RETRIEVED BUT THE EYELET REMAINED IN THE PATIENT. ANOTHER SWIVEL LOCK WAS USED AND THE CASE WAS CONTINUED AND COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE BUT THE TWO EYELETS STILL REMAIN IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 12124174 ↗
• MalfunctionJun 21, 2021Loose or Intermittent Connection; Mechanical Problem

  IT WAS REPORTED DURING A PATELLA TENDON REPAIR THE GREEN HANDLE TAP BECAME LOOSE AND WAS JUST SPINNING. THE HANDLE HAD TO BE SAWED OFF AND THEN THE TAP WAS REMOVED AFTER CHUCKING IT UP TO THE DRILL THEN RUNNING IT IN REVERSE. ALL WAS REMOVED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE. THE PATIENT WAS (B)(6) AND THE BONE QUALITY WAS VERY HARD.

  Patient problems: Insufficient Information

  MAUDE report 12032531 ↗