MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; SCALPEL, ULTRASONIC, REPROCESSED

Model Number HARH36

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the blade was fractured and separated from the device tip.The broken tip was not returned.Inspection of the fractured blade revealed signs of gouging and outer coating erosion as a result of activating against solid/hard materials.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 cause(s) are: too much force or torque applied to instrument, or grasping/pulling; incidental and prolonged activation against solid surfaces, such as bone or plastic; attempting to bend, sharpen, or otherwise alter the shape of the blade.The instructions for use (ifu) state: use the torque wrench (already mounted to the shaft) to tighten the blade onto the hand piece.Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice indicating that sufficient torque has been applied to secure the blade.Do not attempt to bend, sharpen, or otherwise alter the shape of the blade.Doing so may cause blade failure and user or patient injury.Avoid contact with any and all other instruments while the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.Note: do not use any other means than the torque wrench to attach or detach the instrument from the hand piece.- note: do not torque the instrument by hand without the torque wrench or damage may occur.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the tip came off at the end of surgery and fell onto the drape.The device was removed from the field and bagged for pick up.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-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 16677729
• MDR Text Key: 313061906
• Report Number: 0001056128-2023-00011
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327346251
• UDI-Public: 07613327346251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161693
• 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: 04/04/2023

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
• Device Operator: Health Professional
• Device Model Number: HARH36
• Device Catalogue Number: HARH36RR
• Device Lot Number: 14189441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• 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