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	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed, the spring is missing and the device is unusable.The cause is undetermined, however a likely cause is mishandling the device.
Event or Problem Description
It was reported that the thread is defective and therefore the device cannot be fixed on the reamer.There was no harm or adverse event for patient, operator or third party reported.No further information received.

• 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: 19132835
• Report Number: 1220246-2024-02110
• Device Sequence Number: 15176408
• 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): 04/18/2024

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: 051647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown