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

Model Number	PLATE CUTTER
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-18700-28 plate cutters silicone piece came out.This occurred during a case, with no patient effect reported.There was no additional information provided, additional information has been requested.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-18700-28 serial/batch number (b)(6) was received for investigation.Manual functional testing found that the device was working as required.However, the instrument was not used to cut any part.Visual evaluation noted discoloration marks.Per drawing c18004 at revision 3 component description.Item 7.Silicone insert (not shown) it is inferred that the instrument has a silicone component.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• 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: vik bajnath ; 8009337001
• MDR Report Key: 17054446
• Report Number: 1220246-2023-06834
• Device Sequence Number: 6984813
• Product Code: LXH
• UDI-Device Identifier: 00888867317833
• UDI-Public: 00888867317833
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/30/2024

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: PLATE CUTTER
• Device Catalogue Number: AR-18700-28
• Device Lot Number: 672231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown