Tecomet AR-8943-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841435116887), received between Jan 3, 2025 and Feb 3, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Component Missing; Material Twisted/Bent

  ON 13-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-07 BONE REDUCTION FORCEPS TIP WAS MISSING AND THE OTHER WAS BENT. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249187 ↗
• MalfunctionOct 23, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-07 BONE REDUCTION FORCEPS CLAMP TIPS BENT AND BROKE OFF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367395 ↗
• MalfunctionMay 15, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 04/21/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY.2) AR-8943-07 CURVED, POINTED BONE REDUCTION FORCEPS WERE BENT AT THE TIPS AND NOT WHERE THEY WERE SUPPOSED TO BE. THEY WERE DISCOVERED DURING A CASE, BUT NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029757 ↗
• MalfunctionMay 15, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 04/21/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY.2) AR-8943-07 CURVED, POINTED BONE REDUCTION FORCEPS WERE BENT AT THE TIPS AND NOT WHERE THEY WERE SUPPOSED TO BE. THEY WERE DISCOVERED DURING A CASE, BUT NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029753 ↗
• MalfunctionFeb 3, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANKLE FRACTURE SURGERY THE TIPS OF THE DRIVER AR-9844DH AND THE TIP OF THE AR-8943-07 BECAME BENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY THE SAME DEVICE 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 21293560 ↗
• MalfunctionJan 23, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE CUSTOMER WAS USING THE ARTHREX ANKLE FRACTURE SYSTEM A LOT AND THE INSTRUMENTS HAVE GOTTEN BROKEN. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THIS WAS NOTICED DURING AFTER THE SURGERY. THERE WAS NO CASE INVOLVEMENT. NO FURTHER INFORMATION RECEIVED. ***UPDATE DW 09-JAN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE DEVICES FAILED DURING MULTIPLE SURGERIES. DURING AN ANKLE FRACTURE SURGERY THE REPORTED AR-8944DH BECAME TWISTED AND THE AR-8943-07 WAS BENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE 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 21218042 ↗
• MalfunctionJan 3, 2025Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-07 BONE REDUCTION FORCEPS TIP IS BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067115 ↗