Gauthier Biomedical AR-7801Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00858325005176), received between Feb 14, 2022 and Feb 13, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Positioning Failure

  ON 27-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7801 CERCLAGE TENSIONER RATCHETING HANDLE AND AN AR-7800 FIBERTAPE CERCLAGE TENSIONER KNOT SLIPPED AND DID NOT TIGHTEN. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337176 ↗
• MalfunctionApr 22, 2024Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT DURING A DISTAL FEMUR FRACTURE SURGERY THREE FIBERTAPES (AR-7267, LOT S705864) BROKE INSIDE THE PATIENT WHILE USING THE CERCLAGE TENSIONER (AR-7800, LOT 051650). ONE BROKE DURING INITIAL TENSIONING AND THE SECOND AND THIRD BROKE WHEN THE FINAL TENSIONING ON TOP OF THE HALF HITCH WAS DONE. ALL THREE DEVICES BROKE IN THE KNOT. THE BROKEN DEVICE CERCLAGE WAS REMOVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. THE SURGEON SWITCHED TO A CERCLAGE WIRE IN METAL. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155056 ↗
• MalfunctionOct 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 9/22/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06038847 THAT AN AR-7800 FIBERTAPE CERCLAGE TENSIONER AND AN AR-7801 CERCLAGE TENSIONER RATCHETING HANDLE HAD AN ISSUE, THE TENSIONER WAS CUTTING THE TAPE WHEN TENSIONING. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2023 WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/26/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA PHONE: THIS OCCURRED DURING A STERNAL CLOSURE PROCEDURE. WHEN THE TENSIONER WAS CUTTING THE TAPE, ALL FRAGMENTS OF THE TAPE WERE REMOVED FROM THE PATIENT. A DISPOSABLE TENSIONER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT REPORTED AND NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975456 ↗
• MalfunctionOct 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7800 FIBERTAPE CERCLAGE TENSIONER AND AN AR-7801 CERCLAGE TENSIONER RATCHETING HANDLE HAD AN ISSUE, THE TENSIONER WAS CUTTING THE TAPE WHEN TENSIONING. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2023 WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA PHONE: THIS OCCURRED DURING A STERNAL CLOSURE PROCEDURE. WHEN THE TENSIONER WAS CUTTING THE TAPE, ALL FRAGMENTS OF THE TAPE WERE REMOVED FROM THE PATIENT. A DISPOSABLE TENSIONER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT REPORTED AND NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975432 ↗
• MalfunctionFeb 14, 2022Improper or Incorrect Procedure or Method; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ARTHRO ASSISTED LATARJET SURGERY THE PATIENT¿S CORACOID WAS TORN THROUGH BY THE FIBERTAPE CERCLAGE SYSTEM AND HALF OF THE GLENOID WAS TORN THROUGH DUE TO A MISUNDERSTANDING REGARDING THE USED TENSIONER AND THE SCALE, WHICH LED TO A FALSE ADJUSTMENT OF THE TENSIONER OF ABOVE 350 NEWTONS. TWO TENSIONERS WERE SENT OUT FOR THIS CASE WHICH WAS AN ARTHROSCOPIC ASSISTED LATARJET CERCLAGE. THE TENSIONER LISTED (AR-7800 AND AR-7801) PLUS THE BLUE ACL TENSIONER AR-1529. AR-1529 IS THE TENSIONER THAT WAS PREVIOUSLY ALWAYS USED BY THE ARTHREX EMPLOYEE, WHICH MAX¿S OUT AT JUST OVER 100 NEWTONS WITH THE UNIT OF MEASURE LISTED ON THERE IN LBF AND NEWTONS. THE CASE WENT REALLY WELL UNTIL TENSIONING WHERE THE ARTHREX EMPLOYEE DIDN¿T REALISE THAT THE SURGEON WAS USING THE BLACK TENSIONER (AR- 7800 & AR-7801). THIS TENSIONER DOESN¿T HAVE THE UNIT OF MEASURE LISTED ON IT, AND THE SCALE IS IN LBF. THE SURGEON ASKED HOW MUCH TO TENSION TO AND THE ARTHREX EMPLOYEE REPLIED THAT THE SURGEON CAN MAX THE TENSIONER OUT AS 100 NEWTONS ARE DESIRED, IT MAX¿S OUT AT THAT POINT. THE SURGEON THEN TENSIONED TO AROUND 80 IN LBF SCALE, WHICH WAS OVER 350 NEWTONS. THE PATIENT¿S CORACOID W

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13526738 ↗