Arthrex® AR-1922BCM-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867022904), received between Nov 16, 2016 and Sep 25, 2026 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899173 ↗
• InjurySep 25, 2026Physical Resistance/Sticking

  It was reported that during a shoulder surgery the surgeon couldn't unscrew the handle, and the eyelet wouldn't come off; the surgeon forced it to come off and ended up tearing everything apart. 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.Update 04-Sep-2026:A user report was provided with further information. It was further reported that the anchor holder did not release the anchor after impaction. Failure to pose. The practitioner used another provider's anchor. There was a light patient harm, as one additional anchor hole had to be drilled. After impaction of the anchor, it was impossible to remove the anchor holder with its handle. The surgeon needed to tear off the assembly to remove everything.

  Patient problems: Insufficient Information

  MAUDE report 50896590 ↗
• InjurySep 25, 2026Positioning Failure

  It was reported that during a shoulder surgery the surgeon couldn't unscrew the handle, and the eyelet wouldn't come off; the surgeon forced it to come off and ended up tearing everything apart. 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.Update 04-Sep-2026:A user report was provided with further information. It was further reported that the anchor holder did not release the anchor after impaction. Failure to pose. The practitioner used another provider's anchor. There was a light patient harm, as one additional anchor hole had to be drilled. After impaction of the anchor, it was impossible to remove the anchor holder with its handle. The surgeon needed to tear off the assembly to remove everything.

  Patient problems: Insufficient Information

  MAUDE report 50896418 ↗
• InjurySep 25, 2026Physical Resistance/Sticking

  It was reported that during a shoulder surgery the surgeon couldn't unscrew the handle, and the eyelet wouldn't come off; the surgeon forced it to come off and ended up tearing everything apart. 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.***Update 04-Sep-2026A user report was provided with further information. It was further reported that the anchor holder did not release the anchor after impaction. Failure to pose. The practitioner used another provider's anchor. There was a light patient harm, as one additional anchor hole had to be drilled. After impaction of the anchor, it was impossible to remove the anchor holder with its handle. The surgeon needed to tear off the assembly to remove everything.

  Patient problems: Insufficient Information

  MAUDE report 50896187 ↗
• MalfunctionSep 18, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50822819 ↗
• MalfunctionSep 18, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50821729 ↗
• MalfunctionSep 18, 2026Physical Resistance/Sticking

  It was reported that during a shoulder surgery the surgeon couldn't unscrewed the handle, and the eyelet wouldn't come off; the surgeon forced it to come off and ended up tearing everything apart. 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 50819583 ↗
• MalfunctionSep 18, 2026Physical Resistance/Sticking

  It was reported that during a shoulder surgery the surgeon couldn't unscrewed the handle, and the eyelet wouldn't come off; the surgeon forced it to come off and ended up tearing everything apart. 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 50819571 ↗
• MalfunctionSep 18, 2026Physical Resistance/Sticking

  It was reported that during a shoulder surgery the surgeon couldn't unscrewed the handle, and the eyelet wouldn't come off; the surgeon forced it to come off and ended up tearing everything apart. 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 50819547 ↗
• MalfunctionSep 17, 2026Positioning Failure

  It was reported that during an arthroscopic rotator cuff repair surgery the surgeon drove the second-row anchor into the shoulder. The guide wire entered the shoulder, but the anchor remained stuck on the guide wire and did not seat. Unable to place this anchor, a second anchor was taken from the same batch; the surgeon succeeded in seating the anchor, but observed a resistance between the guide wire and the anchor. 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 50804013 ↗
• MalfunctionSep 17, 2026Positioning Failure

  It was reported that during an arthroscopic rotator cuff repair surgery the surgeon drove the second-row anchor into the shoulder. The guide wire entered the shoulder, but the anchor remained stuck on the guide wire and did not seat. Unable to place this anchor, a second anchor was taken from the same batch; the surgeon succeeded in seating the anchor, but observed a resistance between the guide wire and the anchor. 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 50804001 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE AR-1922BCM-1 BROKE OFF WHILE THE SURGEON WAS INSERTING IT INTO THE PATIENT. 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 23378864 ↗
• MalfunctionAug 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED DURING THE SHOULDER ARTHROSCOPY THAT THE METAL TIP DETACHED FROM THE DEVICE AFTER THE SECOND OR THIRD STRIKE WITH THE HAMMER. AFTER RETRIEVING THE METAL TIP, THE SURGEON WAS ABLE TO REATTACH IT TO THE DEVICE, REPEAT THE PROCESS AND IMPLANT THE ANCHOR. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729481 ↗
• MalfunctionAug 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED DURING THE SHOULDER ARTHROSCOPY THAT THE METAL TIP DETACHED FROM THE DEVICE AFTER THE SECOND OR THIRD STRIKE WITH THE HAMMER. AFTER RETRIEVING THE METAL TIP, THE SURGEON WAS ABLE TO REATTACH IT TO THE DEVICE, REPEAT THE PROCESS AND IMPLANT THE ANCHOR. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729444 ↗
• MalfunctionSep 14, 2021Break

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO INSCREW THE IMPLANT HOLDER WHICH RESULTED IN A REMOVAL OF THE DEVICE. IT WAS NOT POSSIBLE TO REIMPLANT THE DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. ON 16-AUG-2021: UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING A SURGERY AND THE SURGEON HAD TO SWITCH FROM A DOUBLE ROW SUTURE TO A SINGLE ROW. ON 23-AUG-2021: UPDATE IT WAS FURTHER REPORTED THAT THE REPORTED EVENT OCCURRED DURING A ROTATOR CUFF SURGERY. ON 24-AUG-2021: UPDATE: FURTHER DETAILS ABOUT THE EVENT WERE PROVIDED. DURING THE SURGERY IT WAS NOT POSSIBLE TO INSCREW THE IMPLANT HOLDER. DUE TO THIS FAILURE THE DEVICE BROKE WHILE FORCING ON THE SCREWDRIVER. THEREFORE IT WAS NOT POSSIBLE TO REIMPLANTING ANOTHER ANCHOR AT THIS PLACE SINCE A PIECE OF THIS ANCHOR REMAINED IN THE PATIENT AND THE SURGERY WAS THEN FINISHED WITH A SINGLE ROW SUTURE INSTEAD OF A DOUBLE ROW. ON 25-AUG-2021: UPDATE: FURTHER INFORMATION WERE PROVIDED BY THE SURGEON THAT THE INITIALLY PROVIDED INFORMATION WAS NOT CORRECT. THE IMPLANT COULD NOT BE DETACHED FROM THE METAL TIP. THE SURGEON HAD TO PULL ON THE HANDLE TO REM

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 12466915 ↗
• MalfunctionJul 27, 2021Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY SURGERY BOTH ANCHOR DID BREAK OFF RIGHT AWAY WHILE ATTACHING TO THE BONE AND SLIGHTLY HAMMERING. THE BROKEN OFF PIECES HAVE BEEN RETRIEVED FROM 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231716 ↗
• InjuryNov 16, 2016Partial Blockage

  IT WAS ORIGINALLY REPORTED THAT THE THREAD WAS BLOCKED AND THE IMPLANT/TIP CAN`T BE TURNED. NO ADVERSE CONDITION REPORTED. FOLLOW-UP INVESTIGATION: THE OPEN ROTATOR CUFF SURGERY WAS FINISHED SUCCESSFULLY BY SWITCHING TO A TRANS-OSSEOUS JOINT TECHNIQUE. SURGERY TOOK 15 MINUTES LONGER. PATIENT HAVE NO IMPAIRMENTS AND HE IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6105388 ↗