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

Model Number	QUAD TENDON GRAFT CUTTING GUIDE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1220246-2021-04043
• Device Sequence Number: 4389618
• Product Code: MDM
• UDI-Device Identifier: 00888867098237
• UDI-Public: 00888867098237
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 12/07/2021

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 Model Number: QUAD TENDON GRAFT CUTTING GUIDE
• Device Catalogue Number: AR-2383
• Device Lot Number: 012023
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown