MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE CERCLAGE SUTURE; CERCLAGE, FIXATION

Model Number	FIBERTAPE CERCLAGE SUTURE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
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.

• Brand Name: FIBERTAPE CERCLAGE SUTURE
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11581750
• Report Number: 1220246-2021-02787
• Device Sequence Number: 3547012
• Product Code: JDQ
• UDI-Device Identifier: 00888867274129
• UDI-Public: 00888867274129
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K170206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: FIBERTAPE CERCLAGE SUTURE
• Device Catalogue Number: AR-7267
• Device Lot Number: S705864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/29/2021
• Patient Sequence Number: 1