MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVS RASP/TRL STEM SZ 6 LNG; MANUAL INSTR, GENERAL SURGICAL

Model Number	UNIVERS REVS RASP/TRL STEM SZ 6 LNG
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
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 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.The most likely cause of the reported failure is wear and tear.
Event or Problem Description
It was reported that during a univers revision revers cta procedure complications occurred.Due to the fact that the trial implant is smaller than the regular implant ar-9501-06rcpc problems occurred.As the surgeon has not removed all the cement in the lower part of the humerus the trail implant fit in but the regular implant did not.Due to this failure the procedure became more complicated.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.03-aug-2022 update dw: further information were provided that a spacer from an unknown manufacturer was placed inside the patient as she had multiple surgeries prior to the reported revision.It is unknown what prosthesis was implanted prior to the multiple surgeries.No further information are avaialble what device was initially implanted and when the initial surgery was performed.

• Brand Name: UNIVERS REVS RASP/TRL STEM SZ 6 LNG
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19319089
• Report Number: 1220246-2024-03299
• Device Sequence Number: 15351423
• Product Code: MDM
• UDI-Device Identifier: 00888867061675
• UDI-Public: 00888867061675
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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 REVS RASP/TRL STEM SZ 6 LNG
• Device Catalogue Number: AR-9510-06R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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