Arthrex® AR-1934PS-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867024182), received between Dec 7, 2021 and Aug 25, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED DURING THE BANKART REPAIR SURGERY THAT THE ANCHOR BROKE INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884092 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED DURING THE BANKART REPAIR SURGERY THAT THE ANCHOR BROKE INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883953 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED DURING THE BANKART REPAIR SURGERY THAT THE ANCHORS BROKE INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883923 ↗
• MalfunctionMar 26, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 6TH MARCH 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1934PS-2, SUTURE ANCHOR, PEEK SUTURE TAK® 3 MM X 12.2 MM WITH #2 FIBERWIRE® AND #2 TIGERWIRE'S ANCHOR WAS STUCK DURING INSERTION. THIS WAS DISCOVERED DURING A REPAIRING OF SHOULDER GLENOID LABIAL INJURY SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-1934PS-2. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699709 ↗
• MalfunctionJun 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1934PS-2, SUTURE ANCHOR, PEEK SUTURE TAK® 3 MM X 12.2 MM WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, THE ANCHOR AND SUTURE WERE PULLED OUT. THIS WAS DISCOVERED DURING USE IN AN ELBOW JOINT LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2024. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934PS-2. THERE WERE NO BROKEN PIECES IN THE PATIENT. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546695 ↗
• MalfunctionSep 5, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1934PS-2 PEEK SUTURE TAK ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A RIGHT RCR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED BY REMOVING ALL THE BROKEN FRAGMETNS AND USING ANOTHER AR-1934PS-2 PEEK SUTURE TAK.

  Patient problems: Insufficient Information

  MAUDE report 17685836 ↗
• MalfunctionJul 28, 2023Break; Break

  ON(B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1934PS-2 PEEK SUTURE TAK ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A RECONSTRUCTION OF ANTERIOR TALOFIBULAR LIGAMENT PROCEDURE ON 6/28/2023. THE CASE WAS COMPLETED USING ANOTHER AR-1934PS-2 PEEK SUTURE TAK FROM THE SAME LOT NUMBER. ALL THE BROKEN FRAGMENTS WERE SUCCESSFULLY RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 17417508 ↗
• MalfunctionDec 7, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR 1934PS-2 PEEK SUTURETAK TIP BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12953319 ↗