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

Model Number	HAR9F
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.As the complaint device was not returned for evaluation, inspection was unable to be performed.A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to the following: applying improper or unnecessary directional or rotational force to connect instrument to hand piece.Accessory device damage (e.G.Hand piece connector damage).Exceeding torque wrench lifespan (e.G.Usage in multiple cases or devices).The instructions for use (ifu) state: "do not torque the instrument by hand or damage may occur to the hand piece.Do not use any means other than the torque wrench to attach or detach the instrument from the hand piece." ¿take care to avoid damage to the shears when removing the torque wrench from the instrument." "use the torque wrench to tighten the instrument onto the hand piece.Turn the wrench clockwise while holding the hand piece until it clicks twice, indicating that sufficient torque has been applied to secure the instrument (illustration 3).To ensure properly assembly, do not grip the instrument handle while applying torque with the torque wrench.Caution: do not torque the instrument by hand or damage may occur to the hand piece.Do not use any means other than the torque wrench to attach or detach the instrument from the hand piece"."remove the torque wrench from the instrument.Do not discard the disposable torque wrench until the completion of the surgical case.The torque wrench is used for removal of the instrument from the hand piece following the procedure (illustration 4).In the event the torque wrench falls out of the sterile field, replace with a sterile torque wrench.Do not re-sterilize the disposable torque wrench.Caution: take care to avoid damage to the shears when removing the torque wrench from the instrument." "while holding the hand piece, loosen the instrument by turning the torque wrench counterclockwise.Continue to loosen by turning the instrument manually to completely unscrew it from the hand piece." "to avoid user or patient injury in the event that accidental activation occurs, the instrument blade, clamp arm, and distal end of the shaft should not be in contact with the patient, drapes, or flammable materials while not in use." "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." "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." the reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be re-opened.
Event or Problem Description
It was reported that the surgeon was using harmonic scalpel during surgery.The tip broke off the instrument and the or team had to search for it to ensure that it had not fallen into the patient.The wire jaw of the harmonic scalpel was broken during dissection and the fragment was identified and accounted for by the end of operation.There was no patient injury, medical intervention, or extended procedure time reported.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: 11268482
• Report Number: 0001056128-2021-00006
• Device Sequence Number: 11887904
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: 07613327348248
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 02/02/2021

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: 10/07/2023
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9FRR
• Device Lot Number: 12204880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 41
• Patient Weight: 94