MAUDE Adverse Event Report: ARTHREX, INC. KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2021
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
It was reported during a capsular repair of the knee, the purple handled gap guide broke under a small amount of tensioning/levering.The shorter guide component for the wires snapped off the larger drill guide.All fragments were retrieved and the case was completed.
Additional Manufacturer Narrative
Complaint confirmed.The returned gap drill guide identified that the weld of the guide sleeve on the drill had broken off of the shaft.Sleeve was not returned for evaluation.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11871696
• Report Number: 1220246-2021-03126
• Device Sequence Number: 4269470
• Product Code: MAI
• UDI-Device Identifier: 00888867307513
• UDI-Public: 00888867307513
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE
• Device Catalogue Number: AR-5875-2
• Device Lot Number: 10306718
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1