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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a shoulder prostheses surgery the guide broke into two pieces outside the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully without an additional device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of broken fragments of an ar-9532-36, with batch number 192753000.Therefore, arthrex was able to deduce the most likely cause of the complaint.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-9532-36 univers revers humeral cup screw guide, 36 mm batch number: 192753000 was received for investigation.Visual evaluation of the returned device noted the device had fractured into two pieces.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Manufactured date: 15-aug-2022.

• 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: 21632870
• Report Number: 1220246-2025-01001
• Device Sequence Number: 18017108
• Product Code: MDM
• UDI-Device Identifier: 00888867241596
• UDI-Public: (01)00888867241596(11)220815(10)192753000
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2025

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: 192753000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 09/03/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 08/13/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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