MAUDE Adverse Event Report: ARTHREX, INC. KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE; BIO SOFT TISSUE FIXATN FASTNR

Model Number KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2023

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 (b)(6) 2023, it was reported by a sales representative via email that an ar-5875-2 knee capsule repair implant system with gap drill guide failed during a procedure.Additional information requested.

• Brand Name: KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE
• 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: 17951507
• MDR Text Key: 325926090
• Report Number: 1220246-2023-08235
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867307513
• UDI-Public: 00888867307513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180594
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE
• Device Catalogue Number: AR-5875-2
• Device Lot Number: 15053375
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2023
• Date Device Manufactured: 02/06/2023
• 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