MAUDE Adverse Event Report: STRYKER INSTRUMENTS MAESTRO DRILL (HEADPIECE); DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number REF 5407-120-050

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Swelling/ Edema (4577)

Event Date 04/04/2022

Event Type  malfunction  

Event Description

During surgery on decompressing a chiari malformation- the maestro drill (headpiece) broke.The metal head broke into approx 15-20 different pieces (small springs, screws, etc).The drill was in use inside of the patient when the incident occurred.We believe all the pieces were taken out when this happened.After this incident the surgeon began having issues with brain swelling and bleeding (mannitol was given).Patient was transferred to ct while intubated and under anesthesia.We have been struggling with our maestro drills for the past year.We are turning them over (sterilizing, processing) very frequently, due to only having 4-5.Two months ago, we had an incident where 4 broke.We called the rep.Cpd, the rep, and i went over possible errors occurring on our end, that is causing them to break.The rep informed us, the drills were old, and after being used repeatedly (so frequently) they were more then likely breaking down.The rep informed us, that the handling of the maestro drill on and off the field is being done correctly, and that cpd is taking the correct steps in handling the drill while cleaning and sterilizing.He stated we just need more drills; 6 were ordered and have arrived, the rep will be out later to test them to ensure they are safe to use on the field.Fda safety report id # (b)(4).

• Brand Name: MAESTRO DRILL (HEADPIECE)
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 14074396
• MDR Text Key: 289100044
• Report Number: MW5108865
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF 5407-120-050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Female