MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED

Model Number	HAR9F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.The teflon pad was identified to have pieces flaking off.The blade shows signs of oxidation tempering as a result of high temperature usage.The teflon pad and blade were inspected with a digital microscope at 10x setting which revealed small particles of the teflon pad separating from the device.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root causes are: applying pressure between instrument blade and tissue pad without having tissue between them, prolonged activation, repeated use of instrument beyond intended use.The instructions for use (ifu) state: care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument.If this happens, there may be a system failure signaled by a continuous tone or alert screen when either of the foot pedals or hand control buttons is depressed.Keep the jaws of the device open when backcutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad and increased blade, clamp arm, and distal shaft temperatures.Thermal influences such as fluids or minimal to no tissue in the jaws may affect the presence or timing of the tone change.Blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at the distal end of the shaft.To prevent burn injury, remove any visible tissue buildup at the distal end of the shaft.During and following activation in tissue, the instrument blade and clamp arm may become hot.Avoid unintended contact with tissue, drapes, surgical gowns, or other unintended sites at all times.Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the har9f appears to be defective.The white insulation part of the hand piece started to fall apart in the wound.The harmonic machine was set at the default min 3 max 5.It turned into ¿dust¿ and the doctor removed the visible pieces and irrigated the wound thoroughly.It was a parathyroid exploration.The surgeon explored and irrigated the wound thoroughly and there were no pieces or remaining dust visible although he felt it impossible to say so with 100% certainty that all was removed.There was no patient injury or medical intervention and extended procedure time reported was minimal, 5-10 minutes.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• MDR Report Key: 9216553
• Report Number: 0001056128-2019-00056
• Device Sequence Number: 11359985
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: 07613327348248
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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: 06/03/2022
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9FRR
• Device Lot Number: 10402651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1