MAUDE Adverse Event Report: ARTHREX, INC. DOUBLECUT, 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	DOUBLECUT, 4.0MM X 13CM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/14/2019
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 during a shoulder arthroplasty procedure the ar-8400obe oval burr, and ar-8400dc double cut were leaving metal shavings in the shoulder post acromioplasty.The rep stated it is unknown if only the ar-8400obe was producing shavings, or if both devices were.The debris being produced were between the size of powder and shavings.The case was completed by using suction on the ar-8400dc to remove the shavings.The rep stated it seemed as though all shavings were removed.However, it cannot be confirmed if all shavings were fully suctioned out of the joint.No other burrs were opened.The speed of the console was set at 6200 rpm.Suction on the handpiece was set at 450 mmhg, and the disposable was in reverse.No outflow tubing was used, and suction was on through handpiece during acromioplasty.The bone quality was medium.
Additional Manufacturer Narrative
The complaint could not be confirmed.Visual evaluation revealed no surface damage to the inner diameter of the outer hub, or any damage on the corresponding location at the distal end of the inner tuber that would indicate a site of metal debris production.Material analysis showed the returned ar-8400dc met all as-received specifications.No problem found.

• Brand Name: DOUBLECUT, 4.0MM X 13CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8739476
• Report Number: 1220246-2019-01180
• Device Sequence Number: 1489276
• Product Code: GFA
• UDI-Device Identifier: 00888867043565
• UDI-Public: 00888867043565
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 07/26/2019

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: 02/29/2024
• Device Model Number: DOUBLECUT, 4.0MM X 13CM
• Device Catalogue Number: AR-8400DC
• Device Lot Number: 10293262
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other