MAUDE Adverse Event Report: ARTHREX, INC. PLATE CUTTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	PLATE CUTTER
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.Upon visual inspection, it was noted that cutting insert had broken off.The insert was not returned for investigation.The observed condition is most likely the result of wear and tear damage accumulated over repeated usage.
Event or Problem Description
It was reported on (b)(6) 2022 by a facility representative via sems that an ar-18700-28 plate cutter is damaged non-specifically.This was discovered during an unspecified time with no patient harm.During returned device evaluation, a reportable malfunction was discovered.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that cutting insert had broken off.The insert was not returned for investigation.The observed condition is most likely the result of wear and tear damage accumulated over repeated usage.

• Brand Name: PLATE CUTTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15698166
• Report Number: 1220246-2022-05667
• Device Sequence Number: 5622830
• Product Code: LXH
• UDI-Device Identifier: 00888867317833
• UDI-Public: 00888867317833
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/14/2022

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: 672014
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown