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

Model Number	5407-120-450
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Unable to lock drill bit in place.Dr.Attempted to secure drill bit over sterile field and three small metal pieces fell out of drill attachment.

• Brand Name: NA
• Common Device Name: DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 25300673
• Report Number: 25300673
• Device Sequence Number: 18471239
• Product Code: HBE
• UDI-Device Identifier: 07613327096545
• UDI-Public: (01)07613327096545
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026
• Report Date (Section F): 05/19/2026

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 Model Number: 5407-120-450
• Device Catalogue Number: 5407-120-450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 18 KG
• Date Report Sent to FDA: 05/19/2026