MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK C, CLD 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number BIO-COMP SWVLK C, CLD 4.75X19.1MM

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2023

Event Type  malfunction  

Event Description

On 10/11/2023, it was reported by a distributor via sems-06054825 that an ar-2324bcc biocomposite swivelock c anchor stripped during insertion.This was discovered during a quadriceps repair procedure on (b)(6) 2023.The case was completed using another anchor.The screws didn¿t break but the threads stripped.The eyelet was perfect.

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: BIO-COMP SWVLK C, CLD 4.75X19.1MM
• Type of Device: BIO SOFT TISSUE FIXATN FASTNR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18020005
• MDR Text Key: 326694802
• Report Number: 1220246-2023-08405
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026827
• UDI-Public: 00888867026827
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K203495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BIO-COMP SWVLK C, CLD 4.75X19.1MM
• Device Catalogue Number: AR-2324BCC
• Device Lot Number: 15111504
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1