Arthrex® AR-1923PS-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867023154), received between Mar 2, 2021 and Sep 25, 2026 — 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.

• MalfunctionSep 25, 2026Break

  It was reported that during a surgery the eyelet broke. Per complaint reporter there was no harm for patient, operator or third party. No further information received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897141 ↗
• MalfunctionFeb 20, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SURGERY, THE ANCHOR WAS PULLED OUT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399822 ↗
• MalfunctionApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE DEVICE GOT TORN OUT. NO PART OF THE DEVICE BROKE OFF. 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 19067891 ↗
• MalfunctionJan 4, 2022Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION WHILE INSERTING THE PUSHLOCK INTO THE DRILL WHOLE THE EYELET BROKE OFF. ACCORDING TO THE SURGEON THERE WAS NO HARM 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. THE FOLLOWING DEVICES WERE USED DURING THE PROCEDURE BUT NO DEFECT WAS REPORTED WITH THEM: 4X AR-1923-PS1 LOT: 13995979. 1X AR-6530-1 LOT:112711246. 15-DEC-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT EVERYTHING WAS RETRIEVED OUT OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13152586 ↗
• MalfunctionOct 26, 2021Break

  IT WAS REPORTED THAT DURING A LABRUM STABILIZATION A PART OF THE DEVICE BROKE OFF OUTSIDE THE PATIENT. THERE WAS NO HARM 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. 07-OCT-2021 UPDATE (B)(4). FURTHER INFORMATION WAS PROVIDED THAT THE DEVICE BROKE OFF INSIDE THE PATIENT AND WAS RETRIEVED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697320 ↗
• MalfunctionOct 19, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILISATION SURGERY SOMETHING OF THE DEVICE BROKE. THE SURGEON REPORTED THAT 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 12659488 ↗
• MalfunctionJun 8, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE PUSH LOCK BROKE OFF. THERE WAS NO HARM 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: Insufficient Information

  MAUDE report 11956411 ↗
• MalfunctionMar 2, 2021Break

  IT WAS REPORTED THAT THE SUTURE EYELET OF THE DEVICE BROKE OF INSIDE THE PATIENT. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SHOULDER ASK 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 11398330 ↗