Arthrex® AR-1922PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867022959), received between Mar 6, 2023 and Apr 23, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

• MalfunctionApr 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SURGERY THE EYELID WAS PULLED OUT FROM THE IMPLANT WHEN THE SUTURES WERE CUT. THE ANCHOR BODY REMAINED INSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 15-APR-26: FURTHER INFORMATION WAS PROVIDED THAT CLARIFIES THE ORIGINAL DESCRIPTION. IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE EYELET WAS PULLED OUT FROM THE IMPLANT WHEN THE SUTURES WERE CUT. IT IS BELIEVED THAT THE ANCHOR BODY BROKE AND AFTERWARDS THE EYELET WAS PULLED OUT FROM THE IMPLANT. THE ANCHOR BODY REMAINS IN THE PATIENT WITH SUTURES TIGHTENED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24965098 ↗
• MalfunctionDec 4, 2025Break; Break

  ON 17TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1922PS, SUTURE ANCHOR, PUSHLOCK® 4.5 X 24 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1922PS. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23718014 ↗
• MalfunctionOct 23, 2025Break; Break

  ON 20TH OCTOBER 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-1922PS, SUTURE ANCHOR, PUSHLOCK® 4.5 X 24 MM, THE TIP OF DEVICE BROKE. THIS WAS DETECTED DURING A ROTATOR CUFF PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE DEVICE WAS REPLACED WITH A SPARE ITEM.

  Patient problems: Insufficient Information

  MAUDE report 23371317 ↗
• MalfunctionJul 25, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-1922PS, SUTURE ANCHOR, PUSHLOCK® 4.5 X 24 MM, ITS ANCHOR BROKE WHEN SUTURING. THIS WAS DETECTED DURING A RECONSTRUCTION OF THE CRUCIATE LIGAMENT SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1922PS. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22620785 ↗
• MalfunctionJul 24, 2025Break; Break

  ON 2ND JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-1922PS, SUTURE ANCHOR, PUSHLOCK® 4.5 X 24 MM, ITS ANCHOR BROKE WHEN SUTURING. THIS WAS DETECTED DURING A RECONSTRUCTION OF THE CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1922PS. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589067 ↗
• MalfunctionDec 30, 2024Break; Break

  ON 4TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1922PS, SUTURE ANCHOR, PUSHLOCK® 4.5 X 24 MM, ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A LEFT SHOULDER ARTHROSCOPIC CLEANUP, ACROMIOPLASTY, ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2024. AR-1927PB AND AR-2324PTB WAS USED TO PREPARE BONE SOCKET. THE ANCHOR BROKE DURING INSERTION AND THE FRAGMENTS WERE NOT REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED BY USING ANOTHER NEW AR-1922PS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21036633 ↗
• MalfunctionAug 26, 2024Break; Break

  ON 22ND JULY 2024, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1922PS, SUTURE ANCHOR, PUSHLOCK® 4.5 X 24 MM, ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER NEW AR-1922PS WAS USED. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065438 ↗
• MalfunctionDec 26, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AFTER A SURGERY THE CUSTOMER WAS UNABLE TO READ THE PART AND LOT NUMBER ON THE DEVICE, AS IT IS TOO SMALL, WHICH HAS TO BE ENTERED INTO THE SYSTEM. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395321 ↗
• MalfunctionMay 31, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1922PS ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A CASE, DEVICE BREAKS DURING USE, ALL FRAGMENTS WERE RETRIEVED, NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030267 ↗
• MalfunctionMar 6, 2023Break; Break

  ON 2/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1922PS PUSHLOCK ANCHOR BROKE OFF DURING INSERTION. EVERYTHING WAS RETRIEVED FROM INSIDE THE PATIENT AND AN AR-2323PSL-1 SWIVELOCK WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16484779 ↗