MAUDE Adverse Event Report: ARTHREX, INC. REVERS HUMERAL CUP SCREW GUIDE, 36MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	REVERS HUMERAL CUP SCREW GUIDE, 36MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2024
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
On (b)(6)2024, it was reported by an arthrex employee via (b)(6).That an ar-9532-36 univers revers¿ humeral cup screw guide broke in half.This occurred during a case.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
One unpackaged ar-9532-36 serial/batch number (b)(6) was received for investigation.Upon visual inspection, the device was found to be broken into two pieces, with a section missing from the back.The reported condition is most likely the result of overheating during use caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.Device manufactured date 2016.

• Brand Name: REVERS HUMERAL CUP SCREW GUIDE, 36MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: jared engle ; 8009337001
• MDR Report Key: 19669600
• Report Number: 1220246-2024-06577
• Device Sequence Number: 14231980
• Product Code: MDM
• UDI-Device Identifier: 00888867241596
• UDI-Public: 00888867241596
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: REVERS HUMERAL CUP SCREW GUIDE, 36MM
• Device Catalogue Number: AR-9532-36
• Device Lot Number: 1027261649
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown