MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS TRIAL CUP 36, 135 DEG; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS REVERS TRIAL CUP 36, 135 DEG
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2022
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 may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to wear and tear.
Event or Problem Description
On 12/13/2022, it was reported by a sales representative via email that an ar-9512 stem/cup extraction adapter handle is not threading into the trial cups, as the threads are dull.Also, an ar-9522-135 trial cup is also dull.This was discovered during a procedure.Additional information received on 12/14/2022: this was discovered during an rts procedure on (b)(6) 2022.The cup was removed by hand and case was completed successfully.

• Brand Name: UNIVERS REVERS TRIAL CUP 36, 135 DEG
• 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: 19318705
• Report Number: 1220246-2024-03287
• Device Sequence Number: 7577827
• Product Code: LXH
• UDI-Device Identifier: 00888867061996
• UDI-Public: 00888867061996
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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: UNIVERS REVERS TRIAL CUP 36, 135 DEG
• Device Catalogue Number: AR-9522-135
• Device Lot Number: 250171801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown