MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS VERSION ROD; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS REVERS VERSION ROD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
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 surgery the device broke.The device is still stuck in the device ar-9510-2, batch: 052246-r.The surgery was finished successfully.No further information received.
Additional Manufacturer Narrative
Additional information: b5, d9, g3.
Event or Problem Description
Update kpilz 03-dez-2024: further information were received that the device broke during a shoulder prothesis surgery.The device broke outside of the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-9510-01 arthrex univers revers¿ version rod, serial/batch number (b)(6), was received for evaluation.The device arrived for evaluation separated from the ar-9510-02.Visual inspection revealed that the threaded tip of the device was broken off.The evaluation of the threaded tip discovered nicks and bends in the threads.Functional testing was not performed as the device is damaged.The most likely cause of the reported failure is user error, specifically applying excessive force through leveraging or prying the device.

• Brand Name: UNIVERS REVERS VERSION ROD
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 20795674
• Report Number: 1220246-2024-08650
• Device Sequence Number: 18095074
• Product Code: LXH
• UDI-Device Identifier: 00888867061620
• UDI-Public: (01)00888867061620(11)230504(10)250225102
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

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
• Device Model Number: UNIVERS REVERS VERSION ROD
• Device Catalogue Number: AR-9510-01
• Device Lot Number: 250225102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 01/03/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/05/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• 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