MAUDE Adverse Event Report: ARTHREX, INC. PLATE CUTTER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	PLATE CUTTER
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
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.Complaint confirmed.Upon visual inspection it was noted that one screw used to assemble the cutting insert is missing.The screw was not returned for investigation.The most likely cause of the reported failure is use error.
Event or Problem Description
It was reported on 09/22/2022 by a sales representative via sems that an ar-18700-28 plate cutter and ar-18720p-12 y-plate are malfunctioning." plate was attempted to be cut using minifrag plate cutter that was missing a screw and it cut the plate improperly.".This was discovered during a case with no patient harm.

• Brand Name: PLATE CUTTER
• 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: 19471303
• Report Number: 1220246-2024-04980
• Device Sequence Number: 7441864
• Product Code: LXH
• UDI-Device Identifier: 00888867317833
• UDI-Public: 00888867317833
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: PLATE CUTTER
• Device Catalogue Number: AR-18700-28
• Device Lot Number: 671935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 06/05/2024
• 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