MAUDE Adverse Event Report: ARTHREX, INC. REVERS LEVER-LOCKING BROACH HANDLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REVERS LEVER-LOCKING BROACH HANDLE
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
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 the device is defective.There was no harm for patient, operator or third party reported.No further information was received with this device.It will be processed as repair, not as complaint.Update avoe 01-oct-2024: it was further reported that the failure occurred during a shoulder prosthesis surgery on the (b)(6) 2024.The bolt in the lower part of the bracket is missing and the rasp is unstable in the holder.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual inspection, it was noted the edges of the ar-9510-2 univers revers¿ lever-locking broach handle, had chipped.Pin missing close to the compression link piston is missing from the device.Functional testing was performed and noted that the broach handle locking handle did not lock and close it.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage in the field.Manufacturing date 2019.

• Brand Name: REVERS LEVER-LOCKING BROACH HANDLE
• 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: 20417740
• Report Number: 1220246-2024-08077
• Device Sequence Number: 12812704
• Product Code: LXH
• UDI-Device Identifier: 00888867290464
• UDI-Public: (01)00888867290464(11)190107(10)6402181102
• 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
• Report Date (Section B): 02/04/2025

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 LEVER-LOCKING BROACH HANDLE
• Device Catalogue Number: AR-9510-2
• Device Lot Number: 6402181102
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown