Arthrex® AR-7800Recalls & reported problems
Arthrex, Inc. · FiberTape Cerclage Tensioner, Reusable · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex FiberTape Cerclage Tensioner is a reusable surgical instrument used to tighten sutures during orthopedic procedures. Its 37 reports mostly describe the tool breaking, splitting or tearing, sticking or slipping so it would not tighten properly, and having a burr that cut sutures mid-case, sometimes causing delays. No deaths and no injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00888867273986), received between Feb 14, 2022 and Apr 16, 2026 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Break” (16 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.
Reports received per month
Most reported problems
Device problems
- Break16
- Material Split, Cut or Torn7
- Positioning Failure4
- Use of Device Problem4
- Device Damaged by Another Device2
- Material Deformation2
- Corroded1
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Insufficient Information8
- Failure of Implant1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Material Split, Cut or Torn
ON 18-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A QTY. 2 OF AR-7800 FIBERTAPE CERCLAGE TENSIONERS HAD A BURR INSIDE CAUSING THE SUTURES TO TEAR. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED 07-APR-2026: IT WAS FURTHER REPORTED THAT THIS WAS DISCOVERED DURING A TSA TOTAL SHOULDER PROCEDURE WITH A 30-MINUTE CASE DELAY EXPERIENCED. THE CASE WAS COMPLETED WITH SWIVELOCK ANCHORS AND IT UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903891 ↗MalfunctionApr 16, 2026Use of Device Problem
ON 18-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT A QTY. 2 OF AR-7800 FIBERTAPE CERCLAGE TENSIONERS HAD A BURR INSIDE CAUSING THE SUTURES TO TEAR. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED 07-APR-2026: IT WAS FURTHER REPORTED THAT THIS WAS DISCOVERED DURING A TSA TOTAL SHOULDER PROCEDURE WITH A 30-MINUTE CASE DELAY EXPERIENCED. THE CASE WAS COMPLETED WITH SWIVELOCK ANCHORS AND IT UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897102 ↗MalfunctionApr 13, 2026Positioning Failure
ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-7800 FIBERTAPE® CERCLAGE TENSIONER WAS MALFUNCTIONING; THEY WERE HAVING TO HOLD THE SIDE BOLT IN ORDER FOR THE PIN TO CATCH THE GEAR SO IT WOULD HOLD TENSION. THIS OCCURRED DURING A CASE. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2026 WHERE THE SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THIS EVENT OCCURRED DURING A CABG PROCEDURE. FIBERTAPE CERCLAGE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY OR ADDITIONAL ANESTHESIA ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 24857453 ↗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 24337333 ↗MalfunctionJan 21, 2026Break
ON 06-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7800 FIBERTAPE CERCLAGE TENSIONER HAD A BROKEN TENSION RELEASE MECHANISM SPRING. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24130737 ↗MalfunctionDec 16, 2025Use of Device Problem; Use of Device Problem
ON 11/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7800 TENSIONER IS NOT FUNCTIONING PROPERLY. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION 12/3: REP STATED THAT TENSIONER HANDLE WAS NOT TURNING APPROPRIATELY AND WAS VERY DIFFICULT TO TURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816706 ↗MalfunctionAug 27, 2025Use of Device Problem; Use of Device Problem
ON 08/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7800 FIBERTAPE CERCLAGE TENSIONER CLAVICLE TENSIONER WAS CUTTING THE SUTURES WHEN RELEASING. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903991 ↗MalfunctionJul 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-7800 FIBERTAPE® CERCLAGE TENSIONER GOT STUCK DURING A CASE. IT WOULD NOT TENSION CORRECTLY AND WOULD GET STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22542616 ↗MalfunctionJul 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON 06/11/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-7800 FIBERTAPE CERCLAGE TENSIONER WAS CUTTING THE SUTURES WHEN RELEASING. THIS WAS INVOLVED IN A CASE WITH NO PATIENT HARM OR DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22436744 ↗MalfunctionMay 27, 2025Positioning Failure; Positioning Failure
ON 05/07/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-7800 FIBERTAPE CERCLAGE TENSIONER SPLITS WHEN IT GOES TO TENSION, AND IT DOESN'T MAKE THE KNOTS TIGHT. THE TENSIONING IS LOOSE. THIS OCCURRED DURING A CASE, AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22090007 ↗MalfunctionNov 4, 2024Material Deformation; Material Deformation
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7800 REUSABLE CERCLAGE TENSIONERS. ARE TEARING THE CERCLAGE IMPLANTS. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. "WE USED 2 OF THE HOSPITAL OWNED TENSIONERS AND BOTH TORE THE IMPLANTS. WE THEN POPPED ANOTHER TENSIONER FROM ANOTHER FACILITY AND IT WORKED LIKE NO PROBLEM. UPON FURTHER INVESTIGATION THE TENSIONERS SEEMS TO HAVE ROUGH EDGES WHICH MAY BE WHY THE IMPLANTS ARE TEARING." ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20597588 ↗MalfunctionNov 4, 2024Material Deformation; Material Deformation
ON 10/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7800 REUSABLE CERCLAGE TENSIONERS. ARE TEARING THE CERCLAGE IMPLANTS. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. "WE USED 2 OF THE HOSPITAL OWNED TENSIONERS AND BOTH TORE THE IMPLANTS. WE THEN POPPED ANOTHER TENSIONER FROM ANOTHER FACILITY AND IT WORKED LIKE NO PROBLEM. UPON FURTHER INVESTIGATION THE TENSIONERS SEEMS TO HAVE ROUGH EDGES WHICH MAY BE WHY THE IMPLANTS ARE TEARING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20597483 ↗MalfunctionSep 13, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING A CERCLAGE SURGERY A POOR TIGHTENING OF THE RACK LEADED IN A LOSS OF TENSION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 20215288 ↗MalfunctionJun 20, 2024Break; Break
ON 05/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO AR-7800 FIBERTAPE® CERCLAGE TENSIONERS SCREWS BROKE. THIS WAS DISCOVERED DURING DR. BALDWIN'S STERNAL CLOSURE PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19578237 ↗MalfunctionJun 19, 2024Break; Break
ON 05/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO AR-7800 FIBERTAPE® CERCLAGE TENSIONERS SCREWS BROKE. THIS WAS DISCOVERED DURING DR. (B)(6) STERNAL CLOSURE PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566358 ↗MalfunctionJun 18, 2024Break; Break
IT WAS REPORTED THAT THE AR-7800, FIBERTAPE® CERCLAGE TENSIONER IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 19561415 ↗MalfunctionJun 18, 2024Break; Break
ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-7800 HAD THE RATCHETING MECHANISM BREAK. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE PERFORMED ON (B)(6) 2021. THE DEVICE BROKE OUTSIDE OF THE PATIENT AND NO FRAGMENTS ENTERED THE PATIENT'S BODY. THE CASE WAS COMPLETED USING A BACKUP AR-7800 SET WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560537 ↗MalfunctionJun 6, 2024Break; Break
ON 09/26/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-7800 FIBERTAPE® CERCLAGE TENSIONER FELL APART. THIS WAS DISCOVERED ON (B)(6) 2022 DURING A THA WHILE ATTEMPTING TO TENSION THE FIBERTAPE AROUND THE FEMORAL NECK IT WAS NOTICED THAT THE SPRING WAS MISSING FROM UNDER THE RELEASE TAB. THE SURGEON WAS ABLE TO HOLD THE TAB DOWN WITH ONE HAND AND TENSION WITH THE OTHER AND THE CASE FINISHED WITHOUT INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19475838 ↗MalfunctionJun 4, 2024Break; Break
ON 5/7/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7800 FIBERTAPE CERCLAGE TENSIONER SPRING AND RELEASE LEVER POPPED WHEN THE SURGEON PRESSED THE RELEASE BUTTON. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19460988 ↗MalfunctionMay 28, 2024Break; Break
IT WAS REPORTED THE AR-7800 FIBERTAPE CERCLAGE TENSIONER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19403946 ↗MalfunctionMay 20, 2024Break; Break
THE TENSIONER IS BROKEN. NO PATIENT AFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19350616 ↗MalfunctionMay 15, 2024Break; Break
ON 08/25/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-7800 FIBERTAPE CERCLAGE TENSIONER X2 IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 19318963 ↗MalfunctionMay 10, 2024Break; Break
IT WAS REPORTED BY THE SALES REP THAT DURING A RADIAL HEAD REPLACEMENT PROCEDURE, THE CERCLAGE TENSIONER HANDLE BROKE OFF OF THE MAIN BODY OF THE DEVICE. THE DEVICE DID NOT BREAK INSIDE OF THE PATIENT. THE CASE WAS COMPLETED BY USING A NEW AR-7800 WITHOUT FURTHER ISSUE.
Patient problems: Insufficient Information
MAUDE report 19286368 ↗MalfunctionApr 26, 2024Break; Break
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 19196730 ↗MalfunctionApr 23, 2024Break; Break
IT WAS REPORTED THAT THE SPRING ON THE AR-7800 TENSIONER BROKE AND FELL OUT OF THE DEVICE. THE REP REPORTED THE DEVICE DID NOT BREAK WITHIN THE PATIENT. THE CASE WAS COMPLETED USING THE DEVICE AND HOLDING THE RATCHET MECHANISM DOWN MANUALLY.
Patient problems: Insufficient Information
MAUDE report 19165511 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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