Arthrex® AR-8943-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867052321), received between May 5, 2021 and Sep 20, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionSep 20, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 09/12/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT AN AR-8943-23 LOBSTER CLAW DOES NOT STAY CLOSED/TIGHT WHEN TIGHTENING DOWN ON THE BONE. NO ADVERSE EFFECTS WERE REPORTED TO THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268907 ↗
• MalfunctionSep 18, 2024Positioning Failure; Retraction Problem; Positioning Failure; Retraction Problem

  ON 09/06/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT AN AR-8943-23 LOBSTER CLAW STOPPED RATCHETING DURING A CLAVICLE FRACTURE. THE CLAMP WAS UNABLE TO HOLD ON TO THE BONE AND COULD NOT BE USED. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT THE CLAMP. NOTHING BROKE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248755 ↗
• MalfunctionJun 5, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 08/03/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-8943-23 LOBSTER CLAWS ARE LOOSE AND DO NOT CLAMP PROPERLY. THIS OCCURRED ON (B)(6) 2022 DURING A ANKLE FRACTURE. THE CASE WAS COMPLETED, AND THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473365 ↗
• MalfunctionMay 1, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023 BY A DISTRIBUTOR VIA SEMS THAT AN AR-8943-23 LOBSTER CLAW BROKE IN HALF DURING THE BONY REDUCTION. ALL FRAGMENTS RETRIEVED. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

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

  MAUDE report 16845065 ↗
• MalfunctionJun 14, 2021Break

  IT WAS REPORTED THAT THE AR-8943-23 BROKE DURING USE. A SECOND LOBSTER CLAW WAS BROUGHT IN AND USED TO COMPLETE THE PROCEDURE. THE REP REPORTED THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11990337 ↗
• MalfunctionMay 5, 2021Break

  IT WAS REPORTED THAT ONE OF THE DEVICE ARMS BROKE OFF DURING AN ANKLE FRACTURE CASE. THE BROKEN PART DID NOT GO INTO THE PATIENT AND THE CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777857 ↗