MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS TRIAL SPACER 36+6MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	UNIVERS REVERS TRIAL SPACER 36+6MM
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2023 by a sales representative via sems that an ar-9551-06 trial spacer broke during trial.Case involvement, device broke during use.Per facility: " the instrument was broken in two parts and both pieces were successfully removed.There was no unplanned incision and removal of the broken piece took an additional 10 seconds.A second surgery is not necessary.".
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause can be attributed to damage incurred during the insertion and/or removal process of the device.

• Brand Name: UNIVERS REVERS TRIAL SPACER 36+6MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16361562
• Report Number: 1220246-2023-06257
• Device Sequence Number: 7259381
• Product Code: LXH
• UDI-Device Identifier: 00888867062351
• UDI-Public: 00888867062351
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

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 SPACER 36+6MM
• Device Catalogue Number: AR-9551-06
• Device Lot Number: S505TG000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown