MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER,5.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	BONE CUTTER,5.0MM X 13CM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/19/2022
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 during an autocart ankle arthroscopy surgery the device was used for a few seconds on the bone cartilage and then started right away to show some very small metal particles to come off.Metal particles remained inside the patient.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged ar-8500bc batch number 10872333 was received for investigation.Visual inspection identified heavy, horizontal scratches lines along the outer diameter of the inner tube bone cutter.After removing the outer tube, more horizontal scratches were observed along the tip.Visual signs of wear were also observed proximal to the hub and along the inner and outer tube shaft.Tissue was found to be lodged in the inner and outer tubes.The observed event is most likely caused by user mechanical damage to the device, such as prying/leveraging or excessive bending forces applied during use.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged ar-8500bc batch number 10872333 was received for investigation.Visual inspection identified heavy, horizontal scratches lines along the outer diameter of the inner tube bone cutter.After removing the outer tube, more horizontal scratches were observed along the tip.Visual signs of wear were also observed proximal to the hub and along the inner and outer tube shaft.Tissue was found to be lodged in the inner and outer tubes.The observed event is most likely caused by user mechanical damage to the device, such as prying/leveraging or excessive bending forces applied during use.

• Brand Name: BONE CUTTER,5.0MM X 13CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 15758562
• Report Number: 1220246-2022-05718
• Device Sequence Number: 8220950
• Product Code: GFA
• UDI-Device Identifier: 00888867043732
• UDI-Public: 00888867043732
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2023

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: 03/31/2025
• Device Model Number: BONE CUTTER,5.0MM X 13CM
• Device Catalogue Number: AR-8500BC
• Device Lot Number: 10872333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 10/20/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/28/2022; 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown