MAUDE Adverse Event Report: ARTHREX, INC. UNI REVERS HUMERAL RESECTION DOWNROD; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNI REVERS HUMERAL RESECTION DOWNROD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.One unpackaged ar-9507rgdp-2 uni revers humeral resection downrod, serial/batch number (b)(6) , was received for investigation.Functional testing with ar-9507rg batch# 121449 found that the device is not functioning as required.Visual evaluation found that the down rod spring is missing.The most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.
Event or Problem Description
It was reported that during a univers reverse inverse prosthesis surgery when disassembling the saw gauge, the snap ring broke off.The breakage occurred poutside of the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully.The device was no longer needed and the error occurred during the dismantling process.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: UNI REVERS HUMERAL RESECTION DOWNROD
• 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: 19558657
• Report Number: 1220246-2024-05927
• Device Sequence Number: 4851068
• Product Code: LXH
• UDI-Device Identifier: 00888867266018
• UDI-Public: 00888867266018
• 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
• Report Date (Section B): 06/18/2024

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: UNI REVERS HUMERAL RESECTION DOWNROD
• Device Catalogue Number: AR-9507RGDP-2
• Device Lot Number: 052137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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