MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS T-ROPE SYN-DESMOSIS REPR TI; WASHER, BOLT NUT

Model Number KNOTLESS T-ROPE SYN-DESMOSIS REPR TI

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2021

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

On 10/18/2021, it was reported by a distributor via email that an ar-8926t knotless tight-rope threads broke when passing through the bone tunnel.This was discovered during an procedure on (b)(6) 2021.All broken pieces were retrieved from patient.

• Brand Name: KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
• 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: 12771269
• MDR Text Key: 286059106
• Report Number: 1220246-2021-03913
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867049086
• UDI-Public: 00888867049086
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K043248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/08/2021

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: KNOTLESS T-ROPE SYN-DESMOSIS REPR TI
• Device Catalogue Number: AR-8926T
• Device Lot Number: 24307
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/08/2021
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1