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	Insufficient Information (4580)
Date of Event	09/03/2021
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
On (b)(6) 2021, it was reported by an arthrex employee via sems that an ar-8850bc bone cutter produced debris in a patient's joint while forward burring.This was discovered during use in an unspecified procedure performed on 09/03/2021.The case was completed using a new burr.Additional information: rep returned contact on 9/14, confirmed the batch as 13248045, confirmed all fragments were removed from patient.Confirmed no dualwave tubing and no uninterrupted irrigation flow.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8550bc, batch 13248045 was received for investigation.Visual inspection identified the presence of circumferential grooves worn into the inner diameter of the outer tube hood, consistent with a site of metal debris production.Corresponding grooves were found along the outer diameter of the cutting head.Damage was noted to the shrink tubing at the proximal end of the inner tube.The observed condition is consistent with prying/leveraging against bone and/or hard tissue during use.

• 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: 12507982
• Report Number: 1220246-2021-03693
• Device Sequence Number: 4231011
• Product Code: GFA
• UDI-Device Identifier: 00888867043930
• UDI-Public: 00888867043930
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown