MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER,5.5MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	BONE CUTTER,5.5MM X 13CM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/28/2022, it was reported by a sales representative via email that ar-8550bc bone cutter is creating debris during use.All debris has been removed from the clavicle using a shaver to remove the metal shaving along with the use of a burr to finish the distal clavicle excision.This was discovered during a shoulder arthroscopy procedure on (b)(6) 2022.Case was completed successfully.
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.

• Brand Name: BONE CUTTER,5.5MM 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: 14407261
• Report Number: 1220246-2022-04918
• Device Sequence Number: 4793371
• Product Code: GFA
• UDI-Device Identifier: 00888867043930
• UDI-Public: 00888867043930
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 05/16/2022

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: BONE CUTTER,5.5MM X 13CM
• Device Catalogue Number: AR-8550BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown