MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL CASE(1OF2); MANUAL INSTR, GENERAL SURGICAL

Model Number	UNIVERS REVERS HUMERAL CASE(1OF2)
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the following sets are chipped and need to be replaced: ar-9217c.Ar-9400c4.Ar-9225c.Ar-9226abc.Ar-9226ubc.Ar-9226cc.Ar-9501-hc2.Ar-9501-hc1.Ar-9615c-1.Ar-9615c-2.
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.Complaint confirmed.Three ar-9501hc-1 sets (no batch/sn indicators) were received for investigation.Visual inspection identified scuff markings across the outer coating of the sets that were consistent with wear and tear damage, as well as peeling of the coating within the trays.The most likely cause is the result of repeated cleaning cycles, and it is unknown how many cleaning cycles the trays have been subjected to.

• Brand Name: UNIVERS REVERS HUMERAL CASE(1OF2)
• 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: 19548145
• Report Number: 1220246-2024-05877
• Device Sequence Number: 12445173
• Product Code: MDM
• UDI-Device Identifier: 00888867184091
• UDI-Public: 00888867184091
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/17/2024

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 HUMERAL CASE(1OF2)
• Device Catalogue Number: AR-9501HC-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 06/17/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown