Arthrex® AR-1922BCMRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867022898), received between Aug 15, 2024 and Sep 9, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY WHEN THE PUSHLOCK WAS INSERTED THE TIP FELL OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. 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 23009719 ↗
• MalfunctionSep 3, 2025Failure to Advance; Separation Failure; Failure to Advance; Separation Failure

  IT WAS REPORTED DURING A SURGERY THAT THE ANCHOR DID NOT SEPARATE FROM THE DRIVER AS IT WAS HIT INTO THE BONE. 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 22953155 ↗
• MalfunctionSep 3, 2025Failure to Advance; Separation Failure; Failure to Advance; Separation Failure

  IT WAS REPORTED DURING A SURGERY THAT THE ANCHOR DID NOT SEPARATE FROM THE DRIVER AS IT WAS HIT INTO THE BONE. 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 22953144 ↗
• MalfunctionApr 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A CUFF SURGERY THE ANCHOR CAME ALONG WITH THE SHAFT WHEN THE SHAFT WAS REMOVED. 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 21856832 ↗
• MalfunctionFeb 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A CUFF SURGERY WHILE DRILLING PREHOAL TO GET THE ANCHOR DOWN, TURNING COUNTERCLOCKWISE AS INSTRUCTIONS SAYS BUT WHEN PULLING UP THE ANCHOR FOLLOWS ALONG. TWO ANCHORS FAILED AND THE THIRD ONE THEY DID NOT WANT TO KEEP IT. 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 21460460 ↗
• MalfunctionFeb 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A CUFF SURGERY WHILE DRILLING PREHOAL TO GET THE ANCHOR DOWN, TURNING COUNTERCLOCKWISE AS INSTRUCTIONS SAYS BUT WHEN PULLING UP THE ANCHOR FOLLOWS ALONG. TWO ANCHORS FAILED AND THE THIRD ONE THEY DID NOT WANT TO KEEP IT. 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 21460322 ↗
• MalfunctionFeb 24, 2025Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A CUFF SURGERY WHILE DRILLING PREHOAL TO GET THE ANCHOR DOWN, TURNING COUNTERCLOCKWISE AS INSTRUCTIONS SAYS BUT WHEN PULLING UP THE ANCHOR FOLLOWS ALONG. 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 21445757 ↗
• MalfunctionFeb 12, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A BICEPS TENDON SURGERY THE ANCHOR DID NOT SEPARATE FROM THE DRIVER. 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 21363799 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN AUTOGRAFT CUFF SURGERY THE TIP DID BREAK OFF, IMPOSSIBLE TO USE. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. 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 21170542 ↗
• MalfunctionJan 3, 2025Break; Break

  ON 12/10/2024 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-1922BCM BIOCOMPOSITE PUSHLOCK TIP BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 12/17/2024: THIS WAS DISCOVERED DURING AN RCR PROCEDURE. THE ANCHOR NEVER MADE IT INTO THE BONE AND WAS ABLE TO BE REMOVED FROM THE PATIENT. THE CASE WAS DELAYED FIVE MINUTES WITHOUT ADDITIONAL ANESTHESIA. THE CASE WAS COMPLETED USING AN AR-2324BCSP SWIVELOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067909 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN INSTABILITY REFIXATION LABRUM SURGERY THE TIP OF THE DEVICE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352761 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR WAS DEFECTIVE. THE TIP WAS NOT STABLE AND IS BENT DURING INSERTION. 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 20268458 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR WAS DEFECTIVE. THE TIP WAS NOT STABLE AND IS BENT DURING INSERTION. 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 20268366 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR WAS DEFECTIVE. THE TIP WAS NOT STABLE AND IS BENT DURING INSERTION. 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 20268313 ↗
• MalfunctionAug 15, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1922BCM SUTURE ANCHORS PILOT SNAPPED OFF. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2024, THE PILOT SNAPPED OFF AND COULDN'T BE THREADED BACK ON. ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED USING ANOTHER AR-1922BCM. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 19991830 ↗