MAUDE Adverse Event Report: ARTHREX, INC. PLATE CUTTER, HERCULES STYLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	PLATE CUTTER, HERCULES STYLE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
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
It was reported that the blade on ar-8954-03 hercules plate cutter lot: 561424 was broken while cutting a plate during a case.The patient was not harmed and the case was completed by using a new ar-8954-03.

• Brand Name: PLATE CUTTER, HERCULES STYLE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12267444
• Report Number: 1220246-2021-03467
• Device Sequence Number: 11873998
• Product Code: MDM
• UDI-Device Identifier: 00888867055254
• UDI-Public: 00888867055254
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/03/2021

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, HERCULES STYLE
• Device Catalogue Number: AR-8954-03
• Device Lot Number: 561424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/03/2021
• Patient Sequence Number: 1