MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BAYONET BLD MOD 6.5IN; E-Z CLEAN BAYONET BLADE MOD 6.5 INCH

Model Number	0029M
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: were the green pieces mentioned in event coming from the actual active electrode tip (ptfe coating)? or were they pieces of the plastic insulation on device proximal to active electrode tip? no lot or batch number was provided therefore a device history could not be done.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a lumbar laminectomy the bayoneted cautery tip shed small portions of green insulation coating.The surgeon observed and removed under a microscope with ease.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/13/2020.Investigation summary the device was inspected and there was evidence that the coating came in contact with a rigid instrument, which did mechanical damage to the coating and resulted in loosening of the bond to the substrate.There were mechanical marks present at either end of the missing coating and what looks to be a scrape mark, which resulted in the loosening or flaking of the ptfe coating.The insulation was not detached as reported by the account.Nature and geometry of the missing coating is inconsistent with flaking due to manufacturing, and more consistent with damage to the coating through use of a rigid instrument.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Additional information was requested, and the following was obtained: were the green pieces mentioned in event coming from the actual active electrode tip (ptfe coating)? or were they pieces of the plastic insulation on device proximal to active electrode tip? answer = that is unknown.The tip has been shipped back and may be able to verify upon visual inspection.

• Brand Name: E-Z CLEAN BAYONET BLD MOD 6.5IN
• Common Device Name: E-Z CLEAN BAYONET BLADE MOD 6.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 10534584
• Report Number: 1721194-2020-00049
• Device Sequence Number: 3860202
• Product Code: GEI
• UDI-Device Identifier: 10614559102510
• UDI-Public: 10614559102510
• Combination Product (Y/N): N
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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 Model Number: 0029M
• Device Catalogue Number: 0029M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/13/2020
• Patient Sequence Number: 1