Arthrex® AR-1922PSMRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867022973), received between Feb 20, 2023 and Jan 14, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY, THE PUSH-LOCK ANCHOR CAME LOOSE FROM THE DRILL CHANNEL DURING INSERTION AND HAD TO BE REMOVED FROM THE SHOULDER WITHOUT SUTURES. AFTER REMOVAL, IT WAS NOTED THAT THE ANCHOR BODY WAS DEFORMED. 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 24066636 ↗
• MalfunctionNov 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY, THE PUSH-LOCK ANCHOR CAME LOOSE FROM THE DRILL CHANNEL DURING INSERTION AND HAD TO BE REMOVED FROM THE SHOULDER WITHOUT SUTURES. AFTER REMOVAL, IT WAS NOTED THAT THE ANCHOR BODY WAS DEFORMED. 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 23534820 ↗
• MalfunctionMar 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A REFIXATION OF THE ROTATOR CUFF SURGERY THE TIP OF THE ANCHOR WAS TOO BLUNT OR THE MATERIAL TOO SOFT AND THE TIP GOT BENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 21607122 ↗
• MalfunctionNov 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT BEFORE A ROTATOR CUFF REPAIR SURGERY THE SELF PUNCHING METAL TIP WAS FOUND BENT IN THE PACKAGING. THE SURGEON USED THE DEVICE BUT THE DEVICE FAILED. 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 20798253 ↗
• MalfunctionSep 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A CUFF STITCHING SURGERY THE SCREW AT THE ANCHOR WAS BENT. 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 20334894 ↗
• MalfunctionSep 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE TIP OF THE ANCHOR BROKE WHILE HAMMERING IN. ALL PARTS WERE RETRIEVED. 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 20320382 ↗
• MalfunctionApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR SURGERY THE ANCHOR OF THE DEVICE DID NOT RELEASE FROM THE HANDLE AND THEN PULLED OUT OF THE BONE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19081529 ↗
• MalfunctionMar 6, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE SUTURE ANCHOR, PEEK PUSHLOCK® SP 4.5 MM X 28 MM BROKE OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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. UPDATE AVOE 20-FEB-2024 IT WAS FURTHER REPORTED THAT THE DEVICE BROKE DURING INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848185 ↗
• MalfunctionFeb 20, 2023Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE METAL PART AT THE TOP OF THE ANCHOR WHERE YOU HIT IT FELL OFF. 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 16404668 ↗