MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.; SAW, POWERED, AND ACCESSORIES

Model Number	72203127
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pieces of metal from the burr were coming off and leaving tiny shards in the patient.No patient injuries were reported.
Additional Manufacturer Narrative
Functional inspection was performed and the inner burr did not rotate freely within the outer sheath, friction was felt in the unloaded condition.The inner burr was noted to be hitting the distal tip of the outer sheath.Galling of the inner sheath was noted opposite of the bronze bushing confirming the reported shedding.The condition of the device indicates excessive side loading took place during use causing the reported shedding.Device returned for evaluation device evaluated by the manufacturer evaluation codes updated.

• Brand Name: BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6821170
• Report Number: 1219602-2017-01031
• Device Sequence Number: 16471947
• Product Code: HAB
• UDI-Device Identifier: 03596010655899
• UDI-Public: (01)03596010655899(17)190209(10)50615075
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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: 72203127
• Device Catalogue Number: 72203127
• Device Lot Number: 50615075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1