Arthrex® AR-8943-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867052178), received between Apr 27, 2021 and Aug 21, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 07/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS(B)(6) THAT (2) AR-8943-07 BONE REDUCTION FORCEPS WERE BENT. THIS OCCURRED DURING A CASE WHERE ANOTHER SET THAT HAD FORCEPS THAT CONNECTED WAS USED TO PROCEED.

  Patient problems: Insufficient Information

  MAUDE report 20016651 ↗
• MalfunctionAug 20, 2024Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-8943-07 BONE REDUCTION FORCEPS WERE BENT. THIS OCCURRED DURING A CASE WHERE ANOTHER SET THAT HAD FORCEPS THAT CONNECTED WAS USED TO PROCEED.

  Patient problems: Insufficient Information

  MAUDE report 20008282 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2021 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8943-07 FORCEPS HAD BENT TIPS. THIS WAS DISCOVERED DURING USE IN A PROCEDURE PERFORMED ON (B)(6) 2021. THE CASE WAS COMPLETED USING ANOTHER SET OF FORCEPS WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559745 ↗
• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON 11/07/2022 BY A ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-8943-07 BONE REDUCTION FORCEPS BENT WHEN TRYING TO USE. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457845 ↗
• MalfunctionMay 24, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 08/31/2021 IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-8943-07 BONE REDUCTION FORCEPS THE SHARP PART OF THE TIP IS BENT. A NEW PRODUCT WAS USED, AND THE CASE WAS COMPLETED. THERE WAS NO CASE/PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397297 ↗
• MalfunctionMay 21, 2024Break; Break

  IT WAS REPORTED THAT THE AR-8943-07 IS BENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359383 ↗
• MalfunctionMay 15, 2024Defective Device; Defective Device

  ON 04/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4).THAT (2) AR-8943-07 BONE REDUCTION FORCEPS WERE DAMAGED. THIS OCCURRED DURING A CASE WITH NO PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326000 ↗
• MalfunctionMay 13, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE DEVICE IS BENT AND DOES NOT CLOSE COMPLETELY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. ALSO THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299170 ↗
• MalfunctionApr 30, 2024Break; Break

  ON 12/6/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8943-07 BONE REDUCTION FORCEPS ARE BENT. THIS WAS DISCOVERED DURING A PROCEDURE, PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215238 ↗
• MalfunctionApr 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE AR-8943-24 WEBER CLAMP, THE TIP ARE VERY BENT OR BROKEN OFF. ADDITIONAL INFORMATION 8/3/2021 PER THE SALES REP, THESE DEVICES WERE ACTUALLY NOT USED IN THE CASE, THEY HAD ALTERNATIVE TRAY OPTIONS, AS SHOWN IN THE IMAGES ATTACHED, THE TIPS ON THE CLAMPS ARE EITHER DULL, BENT, OR BROKEN OFF, MAKING THEM UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182673 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THE AR-8943-24 WEBER CLAMP, THE TIP ARE VERY BENT OR BROKEN OFF. ADDITIONAL INFORMATION 8/3/2021 PER THE SALES REP, THESE DEVICES WERE ACTUALLY NOT USED IN THE CASE, THEY HAD ALTERNATIVE TRAY OPTIONS, AS SHOWN IN THE IMAGES ATTACHED, THE TIPS ON THE CLAMPS ARE EITHER DULL, BENT, OR BROKEN OFF, MAKING THEM UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182579 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THE END POINTS ON THE AR-8943-07 CLAMP IS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180590 ↗
• MalfunctionApr 23, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE POINT OF THE AR-8943-07 REDUCTION FORCEPS IS BENT. SEE SOURCE DATA ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163126 ↗
• MalfunctionMar 1, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 02/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-07 BONE REDUCTION FORCEPS ARE BENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816758 ↗
• MalfunctionFeb 6, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 01/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-8943-07 BONE REDUCTION FORCEPS CLAMPS ARE BENT AND CANNOT BE USED PROPERLY. THIS WAS DISCOVERED DURING A CASE WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18654666 ↗
• MalfunctionFeb 4, 2024Break; Break

  ON 01/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-07 BONE REDUCTION FORCEPS AND AN AR-8943-24 WEBER CLAMP BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637541 ↗
• MalfunctionFeb 4, 2024Break; Break

  ON 01/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-07 BONE REDUCTION FORCEPS AND AN AR-8943-24 WEBER CLAMP BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637509 ↗
• MalfunctionApr 27, 2021Break

  IT WAS REPORTED THAT THE POINT OF THE AR-8943-07 REDUCTION FORCEPS TIP BROKE OFF DURING SURGERY AND WAS IMBEDDED IN THE PATIENT AT THE OPERATIVE SITE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11730927 ↗