MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS; WASHER, BOLT NUT

Model Number TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  malfunction  

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a syndesmosis repair surgery with internal brace the device did not work properly.After tightening the sutures the other suture was cut and the surgeon could not tighten it.The device broke inside the patient and all broken pieces were retrieved from the patient.He needed to change the device to a single packed tightrope implant to continue with the procedure.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (ar-8926t).It was not necessary to switch the surgical technique or do a second surgery.

Event Description

It was reported that during a syndesmosis repair surgery with internal brace the device did not work properly.After tightening the sutures the other suture was cut and the surgeon could not tighten it.The device broke inside the patient and all broken pieces were retrieved from the patient.He needed to change the device to a single packed tightrope implant to continue with the procedure.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (ar-8926t).It was not necessary to switch the surgical technique or do a second surgery.

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.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12896568
• MDR Text Key: 286247386
• Report Number: 1220246-2021-04014
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867352278
• UDI-Public: 00888867352278
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K201522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TIGHTROPE XP BUTTRESS PLATE IMPLANT SYS
• Device Catalogue Number: AR-8959TDS
• Device Lot Number: 13403360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/30/2021
• Date Device Manufactured: 05/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1