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

Model Number	7210486
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the blade was activated, metal flakes shed from the inner blade during procedure.The procedure was completed with another blade.No patient injuries or complications were reported.
Additional Manufacturer Narrative
One 7210486 disposable 3.5mm full radius bone cutter blade returned.This product is sold as a box set of six blades.These are not to be sold individually.The device returned is used.It has no obvious disfiguration.This device spins freely and shows no obstruction.Visual inspection of the inner blade shows a light skiving beginning.There are also vertical scratches.The cutting edges are dinged and chipped.These symptoms have been found to cause fine metal shedding.Shedding has been found to be consistent with wear bands created from inadvertent excess side loading pressure being applied to the device.There have been no other reports of this failure mode for this production lot.

• 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: 7178626
• Report Number: 1219602-2018-00051
• Device Sequence Number: 763909
• Product Code: HAB
• UDI-Device Identifier: 03596010494733
• UDI-Public: (01)03596010494733(17)180816(10)50587025
• 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: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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: 02/16/2018
• Device Model Number: 7210486
• Device Catalogue Number: 7210486
• Device Lot Number: 50587025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1