MAUDE Adverse Event Report: STRYKER CORPORATION N/A; DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)

Model Number	8450107530
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor was drilling the patients bone with the precision match head 3.0 mm, it snapped off and broke in the patients bone.We retrieved the pieces out of patients bone.

• Brand Name: N/A
• Common Device Name: DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 10270163
• Report Number: 10270163
• Device Sequence Number: 3294140
• Product Code: HBE
• UDI-Device Identifier: 07613327097023
• UDI-Public: (01)07613327097023(17)230401(10)20087017
• 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): 06/24/2020
• Report Date (Section F): 06/24/2020

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
• Operator of Device: Health Professional
• Device Model Number: 8450107530
• Device Catalogue Number: 8450-107-530
• Device Lot Number: 20087017
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 06/24/2020