MAUDE Adverse Event Report: STRYKER CORPORATION N/A; DISPOSABLE STRAIGHT ROUTER DRILL BIT

Model Number 5407070011

Device Problem Break (1069)

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

Event Date 02/26/2022

Event Type  malfunction  

Event Description

While using the stryker 1.1mm straight router bit the tip of the bit broke off.Surgeon was able to retrieve the piece that broke off in the skull bone.The other part of the bit was removed from the drill handpiece and placed in a bag along with the wrapper for examination.No injury was apparent to the patient.

• Brand Name: N/A
• Type of Device: DISPOSABLE STRAIGHT ROUTER DRILL BIT
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 13720009
• MDR Text Key: 286921731
• Report Number: 13720009
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5407070011
• Device Catalogue Number: 5407-070-011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male