MAUDE Adverse Event Report: ARTHREX, INC. CURVED BONE CUTTER, 4.20MM X 19CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	CURVED BONE CUTTER, 4.20MM X 19CM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that while using the curved bone cutter for the acetabular micro fracture portion of a hip arthroscopy, tiny metal shavings were observed within the joint.Additional information received on 03/19/2020: the rep reported the metal fragments within the joint were very small, but from what they could tell all were retrieved.Dual wave outflow was not used, and there was uninterrupted flow during the use of device.

• Brand Name: CURVED BONE CUTTER, 4.20MM X 19CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9910395
• Report Number: 1220246-2020-01774
• Device Sequence Number: 19615750
• Product Code: GFA
• UDI-Device Identifier: 00888867039186
• UDI-Public: 00888867039186
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: CURVED BONE CUTTER, 4.20MM X 19CM
• Device Catalogue Number: AR-6420CBC
• Device Lot Number: 10386527
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other