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

Model Number HAR9F

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.The teflon pad was missing from the jaw; furthermore, the teflon pad was not returned.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 Description

It was reported the white piece between the sheers was missing/ broken.Surgeon did not notice the piece was missing prior to the start of the case.Surgeon searched for the piece throughout the case, but could not locate during the procedure.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: marissa richmond ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 9354638
• MDR Text Key: 192154648
• Report Number: 0001056128-2019-00061
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: 07613327348248
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2022
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9FRR
• Device Lot Number: 10398868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1