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
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Since the complaint devices of the knee capsule repair implant system with gap¿ drill guide were not returned, a physical evaluation of the devices was not performed.However, without the devices being returned or any photos provided, the reported event is not confirmed.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion.

• Brand Name: KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE
• Common Device Name: 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
• Report Number: 1220246-2023-08235
• Device Sequence Number: 20474344
• Product Code: MAI
• UDI-Device Identifier: 00888867307513
• UDI-Public: 00888867307513
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown