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

Catalog Number 7210486

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8228702
• MDR Text Key: 132503232
• Report Number: 1219602-2019-00043
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010494733
• UDI-Public: 03596010494733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1