MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED F/R,BL,4.5MM,SERIES 3000 /6; SAW, POWERED, AND ACCESSORIES

Catalog Number	7206011
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that metal flakes were shed from the blade.A backup device was available to complete the procedure with no delay or patient injuries reported.
Additional Manufacturer Narrative
One 4.5 mm full radius blades series 3000 device received.This product is sold in a box of six.Only one blade was returned.The complaint stated: ¿metal flakes were shed from the blade.¿ factors affecting device performance include: device ability, surgical ability and surgical site preparation according to instructions for use.There were 3 locations of wear bands and skiving observed along the surface of the inner blade.Shedding symptoms are consistent with wear bands created from inadvertent excess side loading pressure being applied to the device.Per instructions for use: ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿ and ¿irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.¿ this includes testing prior to procedure.Inadequate cooling of the device accelerates device performance degradation.No root cause related to the manufacture of the device was confirmed.

• Brand Name: BOXED F/R,BL,4.5MM,SERIES 3000 /6
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8148568
• Report Number: 1219602-2018-01700
• Device Sequence Number: 13526821
• Product Code: HAB
• UDI-Device Identifier: 03596010440242
• UDI-Public: 03596010440242
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 11/14/2020
• Device Catalogue Number: 7206011
• Device Lot Number: 50735533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1