MAUDE Adverse Event Report: ARTHREX, INC. INST. CASE, UNIVERS II HUM. PREP; ORTHOPEDIC MANUAL SURG INSTR

Model Number	INST. CASE, UNIVERS II HUM. PREP
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
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.Complaint confirmed.Two ar-9226ubc sets (no batch/sn indicators present) 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.This is most likely the result of repeated cleaning cycles, and it is unknown how many cleaning cycles the trays have been subjected to.
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.

• Brand Name: INST. CASE, UNIVERS II HUM. PREP
• 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: 19537567
• Report Number: 1220246-2024-05793
• Device Sequence Number: 6424975
• Product Code: LXH
• UDI-Device Identifier: 00888867304444
• UDI-Public: 00888867304444
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: INST. CASE, UNIVERS II HUM. PREP
• Device Catalogue Number: AR-9226UBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 06/14/2024
• 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