MAUDE Adverse Event Report: ARTHREX, INC. BLURR, 5.0MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BLURR, 5.0MM X 13CM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/27/2019
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.Per reporter, the risk manager will not release the device.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 rotator cuff repair the tip broke off.All was retrieved.It was replaced and the case was continued.The replacement was used but it produced metal shavings.The doctor retrieved the shavings as best he could but some of the shavings were not.The shaver blade was replaced a third time.Waiting for additional information.Additional information obtained 12/02/2019: a total of two ar-8500bl (blurr, 5.0 mm x 13 cm) were used during the rotator cuff procedure.Lot 10345209 was used and the device broke off at the base.The item was in use at the time.The procedure was immediately stopped and the item was promptly retrieved from the patient's body.A new blurr, lot 10027659 was opened and used to continue the surgery.While in use the blurr shaver started releasing metal shavings and the procedure was immediately stopped and a different product was used to finish the procedure.They were not able to retrieve the metal shavings from the patient's body.

• Brand Name: BLURR, 5.0MM X 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9473539
• Report Number: 1220246-2019-01492
• Device Sequence Number: 10877564
• Product Code: GFF
• UDI-Device Identifier: 00888867043749
• UDI-Public: 00888867043749
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: 01/31/2021
• Device Model Number: BLURR, 5.0MM X 13CM
• Device Catalogue Number: AR-8500BL
• Device Lot Number: 10027659
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/16/2019
• 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