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
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 ↗
Other WASHER, BOLT NUT devices
- FIBULINK FGS-1000Synthes GmbH · Washer, Bolt Nut117 reports
- Arthrex® AR-2372BLOArthrex, Inc. · WASHER, BOLT NUT91 reports
- Arthrex® AR-8925SSArthrex, Inc. · WASHER, BOLT NUT79 reports
- Arthrex® AR-8925TArthrex, Inc. · WASHER, BOLT NUT71 reports
- Arthrex® AR-8926TArthrex, Inc. · WASHER, BOLT NUT61 reports
- RipCord STA001KTrimed, INC. · WASHER, BOLT NUT1 recall2 reports
- Arthrex® AR-7000-18TArthrex, Inc. · WASHER, BOLT NUT1 recall0 reports
- Arthrex® AR-8926SSArthrex, Inc. · WASHER, BOLT NUT35 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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