Arthrex® AR-1926BCSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867395213), received between Mar 17, 2023 and Dec 31, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 10-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-19032C FIBERSTITCH RC IMPLANT 1.5 EXPERIENCED DEPLOYMENT ISSUES DURING A SHOULDER ROTATOR CUFF REPAIR AND CUFFMEND PROCEDURE. THE FIRST ANCHOR WAS DIFFICULT TO DEPLOY, AND AFTER DEPLOYING THE SECOND ANCHOR, A BROKEN SUTURE WAS OBSERVED UPON REMOVAL OF THE INSERTER. BOTH SUTURES AND ANCHORS WERE REMOVED FROM THE PATIENT USING A SHAVER AND KINGFISHER INSTRUMENT. A SECOND AR-19032C FIBERSTITCH RC IMPLANT 1.5 WAS OPENED AND FUNCTIONED AS INTENDED. SUBSEQUENTLY, AN AR-1926BCSP BIOCOMPOSITE PUSHLOCK ANCHOR WAS INSERTED, AND TENSION WAS APPLIED TO THE SUTURE. DURING ANCHOR DEPLOYMENT, THE ANCHOR SPLIT LONGITUDINALLY. ALL FRAGMENTS WERE RETRIEVED USING A SHAVER AND KINGFISHER INSTRUMENTS. THE INCIDENT RESULTED IN A 15-MINUTE CASE DELAY WITH NO ADDITIONAL ANESTHESIA ADMINISTERED AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933873 ↗
• MalfunctionDec 18, 2025Break; Break

  ON 11/28/2025, A SALES REPRESENTATIVE REPORTED THAT DURING A CUFFMEND PROCEDURE, AN AR-1926BCSP BIOCOMPOSITE PUSHLOCK ANCHOR EXPERIENCED AN ISSUE. AFTER PRE-PUNCHING THE PILOT HOLE, THE SURGEON ENCOUNTERED MODERATE RESISTANCE WHILE INSERTING THE ANCHOR, NOT EXCESSIVE. USING PROPER TECHNIQUE, THE ANCHOR WAS MALLETED ALONG A TRAJECTORY SIMILAR TO THE PUNCH, BUT THE ANCHOR BODY SHEARED VERTICALLY IN HALF. THE SURGEON SUCCESSFULLY REMOVED ALL FRAGMENTS AND COMPLETED THE CASE USING ANOTHER AR-1926BCSP BIOCOMPOSITE PUSHLOCK ANCHOR IN A DIFFERENT PILOT HOLE. THE CASE WAS DELAYED BY APPROXIMATELY TWO MINUTES, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 12/04/2025: THIS OCCURRED ON (B)(6) 2025 FOR A ROTATOR CUFF REPAIR PROCEDURE. THE BONE WAS ASSESSED AS NORMAL, AND IT IS UNCERTAIN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO PHOTOS WERE TAKEN OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837335 ↗
• MalfunctionNov 26, 2025Break; Break

  ON 11/4/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT DURING A PROCEDURE INVOLVING THE AR-1926BCSP 3.5MM PUSHLOCK ANCHOR, AN ISSUE OCCURRED. THE SURGICAL TEAM HAD PRE-PUNCHED THE LATERAL ROW USING A 3.5MM PUSHLOCK AWL AND PROCEEDED TO INSERT THE AR-1926BCSP ANCHOR. DURING INSERTION, THE EYELET BROKE, RENDERING THE ANCHOR UNUSABLE. THE SURGEON OPTED NOT TO ATTEMPT PLACEMENT WITH ANOTHER AR-1926BCSP AND INSTEAD USED TWO AR-2325PSLC PEEK SWIVELOCK ANCHORS FROM SHELF STOCK TO COMPLETE THE CASE. THE INCIDENT ADDED APPROXIMATELY 2 MINUTES TO THE PROCEDURE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE CUFFMEND PROCEDURE, PERFORMED ON (B)(6) 2025, WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657242 ↗
• MalfunctionAug 20, 2025Positioning Failure; Positioning Failure

  ON 08/01/2025, A SALES REPRESENTATIVE REPORTED A COMPLAINT VIA EMAIL REGARDING AN AR-1926BCSP BIOCOMPOSITE PUSHLOCK ANCHOR. NO ADDITIONAL DETAILS WERE PROVIDED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS RECEIVED ON 08/12/2025: DURING A ROTATOR CUFF REPAIR WITH AUGMENTATION (CUFFMEND) ON 07/31/2025, THE EYELET OF THE AR-1926BCSP BIOCOMPOSITE PUSHLOCK ANCHOR WAS NOT PROPERLY SECURED TO THE IMPLANT AND WAS SUBSEQUENTLY REMOVED AND RETRIEVED. THE CASE WAS COMPLETED USING A REPLACEMENT AR-1926BCSP BIOCOMPOSITE PUSHLOCK ANCHOR. THE PROCEDURE WAS DELAYED BY A FEW MINUTES TO OBTAIN A NEW IMPLANT, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850496 ↗
• MalfunctionJun 19, 2025Break; Break

  ON 05/14/2025, A REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1926BCSP 3.5MM PUSHLOCKS ANCHOR PORTION FELL APART INTO TWO PIECES THEY GOT DOWN TO THE BONE. THIS OCCURRED DURING A CASE WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED ON 06/18/2025 VIA PHONE, WHERE THE SALES REPRESENTATIVE STATED THIS EVENT OCCURRED DURING A ROTATOR CUFF AUGMENTATION. ALL FRAGMENTS WERE RETRIEVED. THE PATIENT HAD A REALLY GOOD BONE QUALITY. THERE WAS A 30-SECOND DELAY THAT REQUIRED NO ADDITIONAL ANESTHESIA, AND ANOTHER AR-1926BCSP 3.5MM PUSHLOCK WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292504 ↗
• MalfunctionDec 30, 2024Break; Break

  ON 12/3/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-1926BCSP 3.5MM PUSHLOCK EYELETS BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2024.

  Patient problems: Insufficient Information

  MAUDE report 21034081 ↗
• MalfunctionDec 30, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-1926BCSP 3.5MM PUSHLOCK EYELETS BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 21033992 ↗
• MalfunctionDec 27, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-1926BCSP PUSHLOCKS SUTURES LOOSENED AFTER CUTTING IT. THE CASE WAS COMPLETED USING A 3.9 SWIVELOCK. THE CASE WAS DELAYED BETWEEN TWENTY TO THIRTY MINUTES. THIS WAS DISCOVERED DURING A CUFFMEND PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 12/9/2024: THE SURGERY TOOK PLACE ON (B)(6) 2024. THE PUSHLOCK ANCHOR WAS REMOVED. NOTHING BROKE IN THE PATIENT. ADDITIONAL ANESTHESIA WAS ADMINISTERED DUE TO THE CASED DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21027207 ↗
• MalfunctionDec 27, 2024Positioning Failure; Positioning Failure

  ON 12/2/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-1926BCSP PUSHLOCKS SUTURES LOOSENED AFTER CUTTING IT. THE CASE WAS COMPLETED USING A 3.9 SWIVELOCK. THE CASE WAS DELAYED BETWEEN TWENTY TO THIRTY MINUTES. THIS WAS DISCOVERED DURING A CUFFMEND PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 12/9/2024: THE SURGERY TOOK PLACE ON (B)(6) 2024. THE PUSHLOCK ANCHOR WAS REMOVED. NOTHING BROKE IN THE PATIENT. ADDITIONAL ANESTHESIA WAS ADMINISTERED DUE TO THE CASED DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21026973 ↗
• MalfunctionJul 24, 2024Break; Break

  ON 06/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-1926BCSP BIOCOMPOSITE PUSHLOCKS AND AN AR-2325PSLC PEEK SWIVELOCK HAD ISSUES. THE FIRST AR-1926BCSP BIOCOMPOSITE PUSHLOCK EYELET BENT AND BROKE OFF THE INSERTER WHEN IT WAS BEING MALLETED DOWN. THE SECOND AR-1926BCSP BIOCOMPOSITE PUSHLOCK WAS MALLETED DOWN, BUT IT WAS DIFFICULT TO BREACH THE CORTICAL SURFACE OF THE BONE. ONCE IT REACHED THE CORTICAL BONE, THE ANCHOR BODY SPLIT IN HALF AROUND THE SELF-PUNCHING EYELET. THE AR-2325PSLC PEEK SWIVELOCK WAS USED TO FILL THE BONE SOCKET THE AR-1926BCSP BIOCOMPOSITE PUSHLOCK CREATED. HOWEVER, THE ANCHOR PULLED OUT OF THE BONE. A 4.75 MM SWIVELOCK WAS USED TO COMPLETE THE REPAIR. THIS WAS DISCOVERED DURING A CUFFMEND PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 7/2/2024: THE SURGERY WAS PERFORMED ON (B)(6) 2024. ALL BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING AN AR-2324PSP PEEK SWIVELOCK.

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

  MAUDE report 19817414 ↗
• MalfunctionJul 24, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-1926BCSP BIOCOMPOSITE PUSHLOCKS AND AN AR-2325PSLC PEEK SWIVELOCK HAD ISSUES. THE FIRST AR-1926BCSP BIOCOMPOSITE PUSH LOCK EYELET BENT AND BROKE OFF THE INSERTER WHEN IT WAS BEING MALLETED DOWN. THE SECOND AR-1926BCSP BIOCOMPOSITE PUSHLOCK WAS MALLETED DOWN, BUT IT WAS DIFFICULT TO BREACH THE CORTICAL SURFACE OF THE BONE. ONCE IT REACHED THE CORTICAL BONE, THE ANCHOR BODY SPLIT IN HALF AROUND THE SELF-PUNCHING EYELET. THE AR-2325PSLC PEEK SWIVELOCK WAS USED TO FILL THE BONE SOCKET THE AR-1926BCSP BIOCOMPOSITE PUSHLOCK CREATED. HOWEVER, THE ANCHOR PULLED OUT OF THE BONE. A 4.75 MM SWIVELOCK WAS USED TO COMPLETE THE REPAIR. THIS WAS DISCOVERED DURING A CUFFMEND PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 7/2/2024: THE SURGERY WAS PERFORMED ON (B)(6) 2024. ALL BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING AN AR-2324PSP PEEK SWIVELOCK.

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

  MAUDE report 19817406 ↗
• MalfunctionJun 26, 2024Break; Break

  ON 5/31/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO AR-19032C RC FIBERSTITCH ANCHORS WERE PRE-DEPLOYED IN THE PACKAGING. ADDITIONALLY, THE TIP OF AN AR-1926BCSP BIOCOMPOSITE PUSHLOCK BROKE DURING INSERTION. ALL BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6)2024.

  Patient problems: Insufficient Information

  MAUDE report 19614328 ↗
• MalfunctionApr 8, 2024Break; Break

  ON 3/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1926BCSP BIOCOMPOSITE PUSHLOCK ANCHOR EYELET BROKE ON IMPACTION. THE BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 3/26/2024: THERE WAS NO DELAY IN THE PROCEDURE, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067350 ↗
• MalfunctionFeb 26, 2024Break; Break

  ON 2/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1926BCSP BIOCOMPOSITE PUSHLOCK ANCHOR AND AN AR-19032C FIBERSTITCH RC HAD AN ISSUE. IN THIS CASE, THEY FIRST NEEDED TO FIXATE THE PATCH MEDIALLY WITH AR-19032C FIBERSITCH RC. THE SURGEON DEPLOYED THE FIRST ANCHOR OF THE AR-19032C FIBERSITCH RC, BUT WHEN THE SURGEON USED THE WHEEL TO DEPLOY THE SECOND ANCHOR, THE WHEEL WOULD NOT BUDGE. THEY CUT THIS ONE OUT AND USED TWO MORE AR-19032C FIBERSTITCH RCS, WHICH WORKED AS INTENDED. TO FIXATE THE PATCH LATERALLY, THE SURGEON USED THE AR-1926BCSP 3.5 SELF-PUNCHING BIOCOMPOSIT PUSH LOCK. THE SURGEON COULD SELF-PUNCH THE FIRST BIT OF THE INSERTER IN WITH EASE. HOWEVER, WHEN HE WENT TO MALLET THE ANCHOR, IT ABNORMALLY SHATTERED. THE BONE QUALITY WAS NORMAL, AND THE ANGLE AT WHICH THE ANCHOR WAS BEING INSERTED WAS THE SAME ANGLE AT WHICH IT WAS PUNCHED. TWO ADDITIONAL AR-1926BCSP PUSH LOCKS WERE IMPLANTED AS INTENDED TO COMPLETE THE REPAIR. NO EXTRA TIME WAS ADDED TO THE CASE, AND NO HARM WAS DONE TO THE PATIENT. THIS WAS DISCOVERED DURING A CUFFMEND PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776489 ↗
• MalfunctionJul 6, 2023Break; Break

  ON 6/9/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-1926BCSP BIOCOMPOSITE PUSHLOCK SHAFT BENT DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 06/12/2023: THE ANCHOR BROKE OFF IN THE PATIENT AND THE ANCHOR WAS REMOVED. THE PROCEDURE PERFORMED WAS A CUFFMEND.

  Patient problems: Insufficient Information

  MAUDE report 17269460 ↗
• MalfunctionApr 28, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1926BCSP BIOCOMPOSITE PUSHLOCK ANCHOR BROKE OFF THE INSERTER DURING IMPLANTATION. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16839143 ↗
• MalfunctionMar 17, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT QTY. 2 OF AN AR-1926BCSP PUSHLOCK HAD AN ISSUE DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023. DURING THE CUFF MEND, WHEN THE SURGEON MALLETED THE FIRST PUSHLOCK, THE SELF-PUNCHING EYELET BROKE OFF THE METAL INSERTER INSIDE THE PATIENT. ALL BROKEN FRAGMENTS WERE REMOVED. ANOTHER AR-1926BCSP PUSHLOCK WITH THE SAME LOT NUMBER WAS OPENED, AND THE SAME MALFUNCTION OCCURRED, THE EYELET ALSO BROKE OFF THE METAL INSERTER INSIDE THE PATIENT, AND ALL FRAGMENTS WERE REMOVED. THE FIRST COMPLAINT DEVICE WAS DISCARDED, AND THE SECOND DEVICE IS AVAILABLE FOR RETURN. THE SURGEON SWITCHED TO AN AR-2324 BCCT SWIVELOCK ANCHOR, LOT NUMBER 14981365, TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO IMPACT OR HARM TO THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564885 ↗