Arthrex® AR-2922BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867197664), received between Sep 6, 2017 and Apr 19, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2024Break; Break

  ON 06/28/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-2922BC BIOCOMPOSITE PUSHLOCK IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME.

  Patient problems: Insufficient Information

  MAUDE report 19147127 ↗
• MalfunctionOct 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 9/26/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AR-2922BC BIOCOMPOSITE PUSHLOCK AND AN AR-1923BC BIOCOMPOSITE PUSHLOCK ANCHORS PULLED OUT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17966823 ↗
• MalfunctionJan 18, 2022Break

  ON 12/27/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-2922BC BIOCOMPOSITE-CORKSCREW BROKE OFF UPON INSERTION. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2021. SURGEON COULD NOT LOCATE THE BROKEN ANCHOR INSIDE THE PATIENT, OUTSIDE IN THE OR FIELD AND COULD NOT DETECT THE ANCHOR VIA X-RAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13281741 ↗
• MalfunctionMar 12, 2021Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A LABRAL REPAIR, SIX AR-2922BCS WERE USED. ONE IMPLANTED FINE, THE OTHER 5 BROKE DURING INSERTION. IN ALL 5 ATTEMPTS, THE EYELET AND AN ANCHOR FRAGMENT REMAINS IN THE PATIENT. PATIENT IS 16 YEAR OLD FEMALE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11475192 ↗
• InjuryNov 6, 2019Component Missing; Device Dislodged or Dislocated

  IT WAS DISCOVERED VIA FACILITY MEDWATCH REPORT ((B)(4)) THAT THE FOLLOWING INCIDENT OCCURRED: WHILE ATTEMPTING TO INSERT THE ANCHOR FOR THE LABRAL REPAIR IT DISLODGED UPON INSERTION AND COULD NOT BE FOUND VISUALLY WITH THE ARTHROSCOPE. ANOTHER ANCHOR WAS OPEN AND UTILIZED CORRECTLY TO COMPLETE THE PROCEDURE. THE INITIAL ANCHOR THAT WAS DISLODGED WAS NOT FOUND AND REMAINED IN THE PATIENT. ARTHREX ANCHOR WAS A BIO-COMPOSITE PUSHLOCK 2.4 X 11.3MM (EXPIRATION DATE 04/30/2021, REFERENCE NUMBER AR-2922BC. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS, DRESSINGS APPLIED AND PATIENT WAS TAKEN TO PACU. ADDITIONAL INFORMATION OBTAINED FROM THE FACILITY CLINICAL RISK SPECIALIST: THE DATE OF THE PROCEDURE WAS (B)(6) 2019. IT IS POSSIBLE THE DEVICE MAY HAVE BEEN SUCTIONED OUT BY THE NEPTUNE DEVICE HOWEVER THEY WERE UNABLE TO CONFIRM THIS. THE DEVICE COULD STILL BE IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9287380 ↗
• InjurySep 6, 2017Break

  IT WAS REPORTED BY A SALES REP THAT DURING A LABRAL REPAIR PROCEDURE, THE 2.4 BIO-COMPOSITE PUSHLOCK WAS INSERTED AND WHILE MALLETTING, THE ANCHOR BROKE. A SECOND ANCHOR WAS OPENED AND AGAIN, THE BIO-COMPOSITE PUSHLOCK BROKE ON INSERTION. THIS HAPPENED THREE MORE TIMES FOR A TOTAL OF 5 DEVICES ALL WITH THE SAME LOT NUMBER (LOT: 10143236). ALL BROKEN PIECES WERE RETRIEVED AND THE ADEQUATE FIXATION WAS FINALLY OBTAINED WITH THE 5 ANCHORS IMPLANTED. FOLLOW UP INVESTIGATION: ALL PIECES OF THE BROKEN IMPLANTS WERE RETRIEVED WITH GRASPERS AND A SHAVER. THE 5 PARTIAL IMPLANTS (OF THE SAME LOT NUMBER) REMAINED IN PATIENT WITH ADEQUATE FIXATION.

  Patient problems: No Code Available

  MAUDE report 6845921 ↗