MAUDE Adverse Event Report: ARTHREX, INC. BUR,SLAP,CLEARCUT,6 FLUT,4.0MMX 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,SLAP,CLEARCUT,6 FLUT,4.0MMX 13CM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed chipping to the clear washer component of the ar-8400css, along with scuff marks to the od of the both the inner and outer tubes, consistent with sites of metal debris production.This event is most likely caused by excessive bending forces applied to the device during use.
Event or Problem Description
It was reported during the rotator cuff the burr started to produce medal shavings.Some of the debris was very small and not all have been retrieved.The doctor was done shaving when the debris was discovered.He did not have to replace it to continue and the case was completed with no further issues.The rep was not in the case and also made the statement an x-ray was not taken to confirm the shavings.

• Brand Name: BUR,SLAP,CLEARCUT,6 FLUT,4.0MMX 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8074699
• Report Number: 1220246-2018-00748
• Device Sequence Number: 1693720
• Product Code: GFF
• UDI-Device Identifier: 00888867043534
• UDI-Public: 00888867043534
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/15/2018

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: 03/31/2023
• Device Model Number: BUR,SLAP,CLEARCUT,6 FLUT,4.0MMX 13CM
• Device Catalogue Number: AR-8400CSS
• Device Lot Number: 10202090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/15/2018
• 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