Arthrex® AR-1593-PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867331303), received between Mar 28, 2022 and Sep 1, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Break

  On (b)(6) 2026, a sales representative reported via email that an AR-1593-P Secondary Fixation Implant System with PEEK SwiveLock Anchor (4.75 x 19.1) would not go into the bone and subsequently broke. This was discovered during a procedure on (b)(6) 2026. The patient outcome was not reported.

  Patient problems: Insufficient Information

  MAUDE report 50544414 ↗
• MalfunctionFeb 23, 2026Break

  ON 05-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1593-P SECONDARY FIXATION WITH PEEK SWIVELOCK ANCHOR IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING A SURGICAL PROCEDURE. AFTER DRILLING AND TAPPING THE BONE USING A LARGER TAP, THE PEEK SWIVELOCK ANCHOR FRACTURED UPON INSERTION. THE REMAINING PORTION OF THE BROKEN ANCHOR WAS REMOVED FROM THE BONE WITHOUT COMPLICATION. THE SURGEON RETAPPED THE SITE, UTILIZED A NEW IMPLANT, AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM. THE EVENT OCCURRED DURING A PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 11-FEB-2026: THIS WAS DISCOVERED DURING A ROOT REPAIR PROCEDURE. THE CASE WAS COMPLETED USING AN AR-2324PSLC PEEK-SWIVELOCK. THE SURGERY EXPERIENCED A MINIMAL DELAY OF APPROXIMATELY FIVE MINUTES. IT IS UNKNOWN WHETHER ANY ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416711 ↗
• MalfunctionDec 24, 2025Break; Break

  ON 5TH DECEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1593-P, IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1, THE 4.75 PEEK SL (FROM AR-1593-P) ANCHOR BROKE IN THE TIBIA WHEN SECURING THE INTERNAL BRACE. NOT ALL THE PIECES WERE RETRIEVED - SOME LEFT IN SITU. THEY TAPPED WITH THE LARGER TAP IN THE PACK (5.2MM). THE SURGEON SAID THE BONE QUALITY WASN'T OVERLY HARD. THIS WAS DETECTED DURING USE IN AN ACL RECON - GRAFTLINK PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW AR-2324PSLC WAS OPENED, NEW HOLE DRILLED, AND IT WENT IN FINE SECOND TIME ROUND.

  Patient problems: Foreign Body In Patient

  MAUDE report 23888255 ↗
• MalfunctionOct 20, 2025Use of Device Problem; Use of Device Problem

  ON 10/14/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1593-P SECONDARY FIXATION WITH PEEK SWIVELOCK ANCHOR IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING USE. THE 4.75 MM SWIVELOCK PEEK ANCHOR STOPPED THREADING, ADVANCING APPROXIMATELY ONE-THIRD TO HALFWAY THROUGH INSERTION, AND BEGAN CRUSHING. NO PIECES BROKE OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT 4.75 MM SWIVELOCK ANCHOR. THE DELAY WAS LESS THAN 15 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS ISSUE OCCURRED DURING AN ACL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335485 ↗
• MalfunctionOct 20, 2025Use of Device Problem; Failure to Advance; Use of Device Problem; Failure to Advance

  ON 10/14/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1593-P SECONDARY FIXATION WITH PEEK SWIVELOCK ANCHOR IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING USE. THE 4.75 MM SWIVELOCK PEEK ANCHOR STOPPED THREADING, ADVANCING APPROXIMATELY ONE-THIRD TO HALFWAY THROUGH INSERTION, AND BEGAN CRUSHING. NO PIECES BROKE OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT 4.75 MM SWIVELOCK ANCHOR. THE DELAY WAS LESS THAN 15 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS ISSUE OCCURRED DURING AN ACL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335092 ↗
• MalfunctionAug 27, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1593-P SECONDARY FIXATION WITH PEEK SWIVELOCK ANCHOR IMPLANT SYSTEM EXPERIENCED ANCHOR BREAKAGE UPON INSERTION DESPITE FOLLOWING THE CORRECT TECHNIQUE. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 08/15/2025: THE EVENT OCCURRED DURING A BTB ACL PROCEDURE ON (B)(6) 2025 INVOLVING SECONDARY FIXATION. THE ANCHOR DID NOT FRACTURE; HOWEVER, THE EYELET AND ANCHOR DETACHED FROM THE INSERTER, WHICH BENT DURING INSERTION. BOTH THE EYELET AND SCREW WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE SURGEON ELECTED TO FORGO SECONDARY FIXATION AND COMPLETED THE PROCEDURE BY TYING KNOTS, WITH NO ADDITIONAL COMPONENTS USED FOLLOWING THE FAILURE OF THE AR-1593-P. NO SIGNIFICANT CASE DELAY OR ADDITIONAL ANESTHESIA WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902337 ↗
• MalfunctionJun 3, 2024Break; Break

  ON 12/30/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1588BTB-2J TIGHTROPE II BTB SUTURE WAS BUNCHED UP AND UNABLE TO PASS THROUGH THE BUTTON. THEN, WHILE ATTEMPTING TO USE AN AR-1593-P PEEK SWIVELOCK, THE EYELET OF THE ANCHOR SNAPPED OFF WHEN THE SURGEON PASSED THE SUTURE THROUGH IT USING A FLAG. THIS WAS DISCOVERED ON THE BACK TABLE WHILE PREPPING THE GRAFT DURING AN ACLR PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED USING A NEW AR-1588BTB-2J TIGHTROPE II BTB AND AN AR-1593-P PEEK SWIVELOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448663 ↗
• MalfunctionMar 28, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIP OF A SWIVELOCK IN AN AR-1593-P ACL IMPLANT SYSTEM BROKE DURING INSERTION. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 13928165 ↗