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	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
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 that during a shoulder arthroscopy procedure, the surgeon was doing a decompression and the oval burr, ar-8400obe was producing metal flakes in the joint.No further information.Additional information requested.Additional information provided 6/12/2019: the shavings looked like glitter in the joint and were probably not retrieved.The case was completed with a new shaver.Additional information provided 6/13/2019: the account has two blades from the case.They also used an ar-8400dc, lot: 10274224.In addition to the ar-8400obe and they aren¿t 100% sure which one produced the metal flakes, so they saved both.
Additional Manufacturer Narrative
The complaint could not be confirmed.Visual evaluation revealed no surface damage to the inner diameter of the ar-8400dc 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: 8735392
• Report Number: 1220246-2019-01176
• Device Sequence Number: 19400827
• 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): 07/08/2019

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: 12/31/2023
• Device Model Number: DOUBLECUT, 4.0MM X 13CM
• Device Catalogue Number: AR-8400DC
• Device Lot Number: 10274224
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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