MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE,3.5 BONE CUTTER FULL RADIUS,DISP; SAW, POWERED, AND ACCESSORIES

Catalog Number	7210486
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the device had shavings that were peeling off.The metal pieces were suctioned out.A backup device was available to complete the procedure with no delay and no patient injuries.
Additional Manufacturer Narrative
One unused 3.5mm full radius bonecutter blades was returned for evaluation.Visually, the part exhibited some signs of tarnish on the inner edgeform.There was no plating issues noted on the inner blade when reviewed under magnification.Functional assessment of the blade confirmed the inner blade rotated freely within the outer blade in the unloaded condition.Silver plating is an smith+nephew process used at the time of manufacture of this blade to improve lubricity and allow for friction free contact between the stainless steel inner and outer blades.The appearance of the "tarnish" and discoloration does not have any adverse effect on the performance of the device, procedure or patient.The tarnishing discoloration is a cosmetic issue only.Without the return of the device that exhibited the reported shedding this investigation could not identify any evidence of product contribution to the reported complaint.Reportedly the bone shavings were suctioned from the surgical site and there was no harm to the patient.Since no harm is being reported and the procedure was completed with a backup.

• Brand Name: BLADE,3.5 BONE CUTTER FULL RADIUS,DISP
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8228702
• Report Number: 1219602-2019-00043
• Device Sequence Number: 18886202
• Product Code: HAB
• UDI-Device Identifier: 03596010494733
• UDI-Public: 03596010494733
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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 Expiration Date: 12/13/2020
• Device Catalogue Number: 7210486
• Device Lot Number: 50741436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 02/24/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1