MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER, CURVED; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	BONE CUTTER, CURVED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
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
On (b)(6) 2021 it was reported by a sales representative via email that an ar-8400cbc bone cutter left metal debris on the left side area where surgeon was working on.This was discovered during an rcr procedure.Surgeon used a new bone cutter to complete case successfully, no patient affected.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8400cbc was received for investigation.Visual inspection under magnification identified circumferential grooves worn into the inner diameter of the outer tube hood and along the outer diameter of the cutting head, indicative of a site of metal debris production.No breakage was noted.The observed condition is most likely the result of prying/leveraging the device against bone and/or hard tissue during use.

• Brand Name: BONE CUTTER, CURVED
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12571021
• Report Number: 1220246-2021-03732
• Device Sequence Number: 3586521
• Product Code: GFA
• UDI-Device Identifier: 00888867043473
• UDI-Public: 00888867043473
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 10/18/2021

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 Expiration Date: 12/31/2025
• Device Model Number: BONE CUTTER, CURVED
• Device Catalogue Number: AR-8400CBC
• Device Lot Number: 12451846
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/18/2021
• Patient Sequence Number: 1