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Arthrex® AR-7267Recalls & reported problems

Arthrex, Inc. · FiberTape Cerclage Suture · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867274129), received between Sep 22, 2020 and Apr 26, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break5

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Insufficient Information1
  • No Code Available1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 26, 2024Break; Break

    IT WAS REPORTED THAT DURING A PERIPROSTHETIC FEMUR FRACTURE FIXATION TWO FIBERTAPE CERCLAGE SUTURES SNAPPED. ONE SNAPPED BEFORE TENSIONING AND THE OTHER SNAPPED AT BEGINNING OF TENSIONING. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19193633 ↗
  • MalfunctionApr 26, 2024Break; Break

    IT WAS REPORTED THAT DURING A PERIPROSTHETIC FEMUR FRACTURE FIXATION TWO FIBERTAPE CERCLAGE SUTURES SNAPPED. ONE SNAPPED BEFORE TENSIONING AND THE OTHER SNAPPED AT BEGINNING OF TENSIONING. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19193540 ↗
  • MalfunctionMar 29, 2021Break

    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 11581750 ↗
  • InjurySep 22, 2020Break

    AN ARTHREX EMPLOYEE HAS REPORTED THAT A PATIENT UNDERWENT A EARLY-ONSET SCOLIOSIS CORRECTION. IT WAS FURTHER REPORTED THAT A ARTHREX FIBER TAPE WAS USED AND BROKE AFTER THE INITIAL SURGERY AND THEREFORE A REVISION WAS PERFORMED. NO FURTHER INFORMATION RECEIVED.

    Patient problems: Insufficient Information

    MAUDE report 10567104 ↗
  • InjurySep 22, 2020Break

    AN ARTHREX EMPLOYEE HAS REPORTED THAT A PATIENT UNDERWENT A EARLY-ONSET SCOLIOSIS CORRECTION. IT WAS FURTHER REPORTED THAT A ARTHREX FIBER TAPE WAS USED AND BROKE AFTER THE INITIAL SURGERY AND THEREFORE A REVISION WAS PERFORMED. NO FURTHER INFORMATION RECEIVED.

    Patient problems: No Code Available

    MAUDE report 10567086 ↗

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Sources and updates

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