Arthrex® AR-1926PSSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867395220), received between Mar 19, 2025 and Jan 2, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1926PSSP 3.5 MM SELF-PUNCHING PUSHLOCK ANCHOR BROKE OFF THE INSERTER DURING INSERTION. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT, AND AN AR-2324PSLC SUTURE ANCHOR, PEEK-SWIVELOCK C, 4.75 X 19.1 MM WAS USED AS A REPLACEMENT. SUBSEQUENTLY, TWO AR-19032C FIBERSTITCH RC IMPLANT 1.5 DEVICES WERE UNABLE TO SEAT AFTER DEPLOYMENT. ALL SUTURES AND ANCHORS WERE REMOVED FROM THE PATIENT, AND A REPLACEMENT AR-19032C FIBERSTITCH RC IMPLANT 1.5 FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THE PROCEDURE WAS DELAYED BY APPROXIMATELY FIVE MINUTES. THIS OCCURRED DURING A SURGERY ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943675 ↗
• MalfunctionJul 30, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  ON 07/08/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1926PSSP 3.5 MM SELF-PUNCHING PUSHLOCK® ANCHOR PULLED OUT AND BROKE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN THE ANCHOR PULLED OUT AND BROKE. THEY WERE ABLE TO REMOVE THE IMPLANT AND REPLACE IT WITH THE SAME PART NUMBER SUCCESSFULLY. THE PATIENT WAS NOT HARMED, AND THE PROCEDURE WAS ABLE TO CONTINUE AND BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667300 ↗
• MalfunctionApr 2, 2025Break; Break

  ON 3/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1926PSSP 3.5 MM SELF-PUNCHING PUSHLOCK TIP BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A CUFFMEND PROCEDURE ON (B)(6) 2025. THE BROKEN FRAGMENTS WERE RETRIEVED. ADDITIONAL INFORMATION REQUESTED ON 3/27/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753543 ↗
• MalfunctionMar 20, 2025Break; Break

  ON (B)(6)2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT QTY. 2 OF AN AR-1926PSSP 3.5 MM SELF-PUNCHING PUSHLOCK ANCHOR HAD AN ISSUE DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2025. THE FIRST ANCHOR WAS IMPLANTED IN THE NORMAL FASHION, BUT THE EYELET BROKE OFF DURING INSERTION. THE EYELET, ANCHOR, AND SUTURES WERE REMOVED FROM THE PATIENT. THE SECOND ANCHOR WAS IMPLANTED INTO THE SAME HOLE, AND AGAIN, THE EYELET BROKE OFF DURING INSERTION. THAT EYELET, ANCHOR, AND SUTURES ALSO WERE REMOVED FROM THE PATIENT, THERE WAS NO HARM. A NEW PILOT HOLE WAS PRE-PUNCHED, AND AN AR-2324BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK, WITH AN UNKNOWN LOT NUMBER, WAS IMPLANTED INSTEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COMPLAINT DEVICES WERE DISCARDED, AND NO PICTURES WERE TAKEN. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652125 ↗
• MalfunctionMar 20, 2025Break; Break

  ON (B)(6)2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT QTY. 2 OF AN AR-1926PSSP 3.5 MM SELF-PUNCHING PUSHLOCK ANCHOR HAD AN ISSUE DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE FIRST ANCHOR WAS IMPLANTED IN THE NORMAL FASHION, BUT THE EYELET BROKE OFF DURING INSERTION. THE EYELET, ANCHOR, AND SUTURES WERE REMOVED FROM THE PATIENT. THE SECOND ANCHOR WAS IMPLANTED INTO THE SAME HOLE, AND AGAIN, THE EYELET BROKE OFF DURING INSERTION. THAT EYELET, ANCHOR, AND SUTURES ALSO WERE REMOVED FROM THE PATIENT, THERE WAS NO HARM. A NEW PILOT HOLE WAS PRE-PUNCHED, AND AN AR-2324BCC SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK, WITH AN UNKNOWN LOT NUMBER, WAS IMPLANTED INSTEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COMPLAINT DEVICES WERE DISCARDED, AND NO PICTURES WERE TAKEN. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652057 ↗
• MalfunctionMar 19, 2025Break; Break

  ON 3/5/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1926PSSP SELF-PUNCHING PUSHLOCK TIP BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED ON 3/12/2025.

  Patient problems: Insufficient Information

  MAUDE report 21644397 ↗