MAUDE Adverse Event Report: ARTHREX, INC. QUAD TENDON GRAFT CUTTING GUIDE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number QUAD TENDON GRAFT CUTTING GUIDE

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, two devices were returned, one of which had a damaged and broken t-slot.The second device appears new and was returned in its original packaging.The cause of the broken t-slot is undetermined, however a likely cause is user-applied mechanical forces.

Event Description

On (b)(6) 2021, it was reported by a facility representative via (b)(6) that an ar-2383 cutting guide was bent.This occurred during a case when the surgeon bent the cutting guide.The case was completed successfully, and there was no patient effect reported.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: QUAD TENDON GRAFT CUTTING GUIDE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 12953203
• MDR Text Key: 285178095
• Report Number: 1220246-2021-04043
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867098237
• UDI-Public: 00888867098237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QUAD TENDON GRAFT CUTTING GUIDE
• Device Catalogue Number: AR-2383
• Device Lot Number: 012023
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1