MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CUTTER BLADE,3.5MM, DSPL,EP-1; SAW, POWERED, AND ACCESSORIES

Model Number	7205308
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a fragmentation of the metal of the blades during procedure.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.
Additional Manufacturer Narrative
One 7205308 3.5 mm full radius ep-1 disposable blade returned.The complaint stated: "it was reported a fragmentation of the metal of the blades during procedure." functional test with a dyonics ep-1 handset and mdu device confirmed that the blade ran forward, reverse and oscillating.It was switched between modes with no issue.There were no error messages indicated on the power control panel.Returns for shedding have been found to be consistent with the device being "tested" without or with insufficient irrigation.These devices are not intended to be engaged without suction.Per the ifu: "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." and it states: "irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry)." there were no fragments observed.There are light dings and scratches on surfaces.Those that are circular are typical of pressure on the blade.This is a symptom of excessive force/side loading.Shedding can also be due to contact with another instrument, device or un-excised bone fragments.No root cause related to the manufacture of the device was established.

• Brand Name: CUTTER BLADE,3.5MM, DSPL,EP-1
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7858537
• Report Number: 1219602-2018-01219
• Device Sequence Number: 11221449
• Product Code: HAB
• UDI-Device Identifier: 03596010251367
• UDI-Public: (01)03596010251367(17)230111(10)50707437
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2018

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: 01/11/2023
• Device Model Number: 7205308
• Device Catalogue Number: 7205308
• Device Lot Number: 50707437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/04/2018; 11/07/2018
• Initial Report FDA Received Date: 09/08/2018
• Supplement Report FDA Received Date: 10/09/2018; 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR