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

Model Number	KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
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.
Event or Problem Description
It was reported that during a knee capsule repair procedure the surgeon was using ar-5875-2, arthrex knee capsule repair system (lot 12170195).During use the guide from the kit broke.Surgeon then tried free-handing the guide's position and both anchors pulled out.Additional information obtained 01/20/2021: date of procedure was (b)(6) 2021.All components/pieces of the ar-5875-2 were fully retrieved and nothing was left in the patient.The surgeon then used suture to complete his repair.All components of the complaint device were discarded at the time of procedure.

• Brand Name: KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11258741
• Report Number: 1220246-2021-02517
• Device Sequence Number: 11809292
• Product Code: MAI
• UDI-Device Identifier: 00888867307513
• UDI-Public: 00888867307513
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE
• Device Catalogue Number: AR-5875-2
• Device Lot Number: 12170195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other