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

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint confirmed.Two unpackaged c15579 gap drill guides from an ar-5875-2 were received for investigation.Visual inspection identified that the c15580 drill guide components from the c15579 gap drill guides had both broken off.One c15580 drill guide fragment was returned, and measurements conducted with digital micrometer id: 224 identified that the component met design specifications.The cause remains undetermined.

Event Description

On (b)(6) 2021, it was reported by a sales representative via email that (2) ar-5875-2 drill guides snapped.This occurred on (b)(6) 2021 during a mensico-capsular repair in conjunction with a meniscal root repair.After the surgeon performed the root portion of the procedure, he had placed the guidewires and began drilling for his suture taks.Upon insertion of the second anchor the gap guide snapped, causing the team to skive with the anchor.A second kit was opened up for the guide, but upon inserting the anchor, the gap guide broke with the anchor staying in the bone.For the third anchor the surgeon chose to freehand the drill instead of opening another kit.

• Brand Name: KNEE CAPSULE REPAIR SYSTEM W/GAP GUIDE
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12793537
• MDR Text Key: 281585403
• Report Number: 1220246-2021-03914
• 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: 11/11/2021

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
• Device Operator: Health Professional
• 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?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1