Arthrex® AR-1938PHSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867097216), received between Apr 12, 2021 and Oct 23, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 10/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SUTURE FROM TWO AR-1938PHS PEEK, KNOTLESS HIP SUTURETAK SHRED WHEN PASSED AROUND THE LABRUM. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515256 ↗
• MalfunctionOct 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 10/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SUTURE FROM TWO AR-1938PHS PEEK, KNOTLESS HIP SUTURETAK SHRED WHEN PASSED AROUND THE LABRUM. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515231 ↗
• MalfunctionOct 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 10/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SUTURE FROM TWO AR-1938PHS PEEK, KNOTLESS HIP SUTURETAK SHRED WHEN PASSED AROUND THE LABRUM. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514785 ↗
• MalfunctionOct 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 10/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE SUTURE FROM TWO AR-1938PHS PEEK, KNOTLESS HIP SUTURETAK SHRED WHEN PASSED AROUND THE LABRUM. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514784 ↗
• MalfunctionJun 7, 2024Material Frayed; Material Frayed

  ON 1/30/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1938PHS PEEK, KNOTLESS HIP SUTURETAK FIBERWIRE FRAYED MULTIPLE TIMES. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2023. ALTHOUGH THE SUTURES FRAYED, SURGEON WAS ABLE TO IMPLANT BOTH AR-1938PHS PEEK, KNOTLESS HIP SUTURETAK TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19492366 ↗
• MalfunctionJun 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN INSTABILITY REPAIR SURGERY ISSUES WITH THE DEVICE OCCURRED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 20-FEB-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE IMPLANTS MENTIONED IN THE APPENDIX DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484139 ↗
• MalfunctionApr 12, 2021Break

  IT WAS REPORTED THAT DURING A HIP LABRAL SUTURING PROCEDURE FIVE DEVICES BROKE DURING THE INSERTION INTO THE BONE. ALL BROKEN PIECES 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647664 ↗