MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE,4.5 BONECUTTER,FR,180MM LG,DSP; SAW, POWERED, AND ACCESSORIES

Catalog Number	7210979
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy, the device was releasing cutler (loosening lint).No back up device was available and no delay or patient injuries were reported.
Additional Manufacturer Narrative
One 7210979 disposable full radius 180mm long bonecutter blade used for treatment was returned.The complaint stated: ¿the device was releasing cutler (loosening lint).¿ there were rotational scoring marks left on the surface of the inner blade.Instructions for use confirms instructions, recommendations and precautionary statements and for proper use of product.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 blade.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ to produce a device with less friction, silicone is used along with a silver plating process for additional lubrication between inner and outer blades.The silver plate surface may become discolored from silver tarnish.It has been determined that the excess silicone located at the bottom of the blade tip, or the appearance of discoloration will not impact the patient or end user.Platinum improves lubricity and allows for reduced frictional contact between the stainless steel inner and outer blades.It also discolors when exposed to certain elements.Testing has confirmed that the silicone lubricant is biocompatible, non-toxic, non-irritating and non-sensitizing.The silicone and silver improves performance of the device and has been determined to have no adverse effect on patient safety.The blade was tested to confirm functionality.The product connected, ran in forward, reverse and oscillating.It switched between modes with no issue.There were no error messages indicated on the control panel.Rate of allegations are monitored.Product met specifications upon release to distribution.

• Brand Name: BLADE,4.5 BONECUTTER,FR,180MM LG,DSP
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9102249
• Report Number: 1219602-2019-01155
• Device Sequence Number: 14148784
• Product Code: HAB
• UDI-Device Identifier: 03596010544001
• UDI-Public: 03596010544001
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2019

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: 09/07/2021
• Device Catalogue Number: 7210979
• Device Lot Number: 50792052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 09/22/2019
• Supplement Report FDA Received Date: 11/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR