Arthrex® AR-1938BCHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867097193), received between Apr 26, 2021 and Feb 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025Break; Break

  ON (B)(6)2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT QTY. 2 OF AN AR-1938BCH SUTURE ANCHOR, BIOCOMPOSITE, KNOTLESS HIP SUTURETAK, AND AN AR-2923BCH SUTURE ANCHOR BIOCOMPOSITE HIP PUSHLOCK HAD AN ISSUE DURING A HIP ARTHROSCOPIC LABRAL REPAIR PROCEDURE ON (B)(6) 2025. WHEN USING THE FIRST AR-1938BCH SUTURE ANCHOR, UPON SHUTTLING THE FIRST REPAIR STITCH THROUGH, THE LEAD STITCH BROKE. ALL STITCHES WERE CUT OUT AND REMOVED, BUT THE ANCHOR REMAINED INSIDE THE PATIENT. WHEN USING THE SECOND AR-1938BCH SUTURE ANCHOR, UPON SHUTTLING THE LEAD STITCH, THE TOP ONE-THIRD OF THE ANCHOR BROKE OFF INSIDE THE PATIENT. THE SURGEON REMOVED ALL STITCHES AND THE BROKEN TOP OF THE ANCHOR, BUT THE REMAINING TWO-THIRDS OF THE ANCHOR STAYED INSIDE THE PATIENT. WHEN USING THE AR-2923BCH SUTURE ANCHOR BIOCOMPOSITE HIP PUSHLOCK, THAT ANCHOR PULLED OUT AFTER INSERTION IN ONE PIECE. EVERYTHING WAS REMOVED FROM THE PATIENT. THE THIRD ANCHOR WAS DISCARDED, AND NO PICTURES WERE TAKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, USING A KNOTLESS FIBERTAK ANCHOR AND A PUSHLOCK ANCHOR WITH UNKNOWN PRODUCT PART NUMBERS. THE CASE WAS DELAYED FOR ABOUT 10 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. T

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315270 ↗
• MalfunctionApr 26, 2021Break

  IT WAS REPORTED DURING A HIP SCOPE PROCEDURE THE ANCHOR BROKE DURING INSERTION. THE DOCTOR WENT TO THE HARD BONE DRILL TO OPEN THE TUNNEL BUT THE SAME ISSUE WITH FOUR OTHER IMPLANTS. ALL WAS RETRIEVED FROM THE PATIENT. HE SWITCHED TO A PUSH LOCK AND EVERYTHING WORKED FINE AND CASE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724456 ↗