MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; BIT, SURGICAL

Model Number 310.35

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/10/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation as the customer stated in the medwatch report that they will be keeping the device for their own purposes.  as the device was not returned to stryker sustainability solutions, evaluation was unable to be performed.No device information was reported and the customer did not report lot # or serial # information.Therefore, the device history record (dhr) was unable to be verified.Therefore, the most likely root causes are: not inspecting device prior to use; too much force applied to device; shipping/handling damage; insufficient structural integrity; wear/dulling of the cutting face requiring higher thrust force applied to device; excessive friction heat; patient bone harder/more dense than anticipated; device not tightened correctly.The instructions for use (ifu) state: observe surgical accessories for damage that could impair proper operation and replace any damaged accessory immediately.Do not employ bent or damaged surgical accessories in surgery.Do not apply excessive lateral force.Before beginning the procedure, verify overall compatibility of all instruments and accessories to be used during the surgical procedure.Inspect the device for overall condition and physical integrity.Do not use if any damage is noted.Return the device and package to stryker's sustainability solutions.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.

Event Description

It was reported the end of the drill bit broke off while drilling into the humeral plate and that the doctor left the remaining drill piece in the head of the humerus.The complainant is not aware of any other patient injury, medical intervention, or extended procedure time.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: BIT, SURGICAL
• 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: 16651772
• MDR Text Key: 312408291
• Report Number: 0001056128-2023-00010
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885825011796
• UDI-Public: 00885825011796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 310.35
• Device Catalogue Number: 310.35RR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other