MAUDE Adverse Event Report: ARTHREX, INC. K-LESS T-ROPE W/DRV, SYN REPR, TI; WASHER, BOLT NUT

Model Number K-LESS T-ROPE W/DRV, SYN REPR, TI

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2021

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 09/10/2021, it was reported by a sales representative via phone that an ar-8935-54 drill guide locking 3.5 screw, head broke off during insertion.All fragments were removed.This was discovered during use in an ankle arthroscopy on 09/07/2021. the case was completed by using an ar-8935-56 screw into the same insertion site.Additional information 9/13/2021 on 09/13/2021, it was reported by a sales representative via email that an ar-8935-54 drill guide locking 3.5 screw head, broke off during insertion.The surgeon cut the ar-8925t, tightrope xp, and remove the broken screw and ar-9943c-04 plate.This was discovered during use in an ankle arthroscopy on (b)(6) 2021. the case was completed by using a new ar-8925t into the same insertion site using the same ar-993-43c-04 plate.

• Brand Name: K-LESS T-ROPE W/DRV, SYN 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: 12540205
• MDR Text Key: 274476333
• Report Number: 1220246-2021-03704
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867281608
• UDI-Public: 00888867281608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/28/2021

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: K-LESS T-ROPE W/DRV, SYN REPR, TI
• Device Catalogue Number: AR-8925T
• Device Lot Number: 13521924
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 09/28/2021
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1