MAUDE Adverse Event Report: STRYKER CORPORATION CARBIDE MATCH HEAD; DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)

Model Number	5820107530C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgical procedure, the carbide drill bit tip was broken off while surgeon was using the drill.Doctor noticed immediately and searched the surgical field for the tip.The tip was not found on or around the surgical field.Doctor used fluoroscopy (c-arm) to search for the tip in the surgical wound.No metal tip piece was seen on x-ray.

• Brand Name: CARBIDE MATCH HEAD
• Common Device Name: DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER CORPORATION; 1941 stryker way; portage MI 49002
• MDR Report Key: 20320858
• Report Number: 20320858
• Device Sequence Number: 15429534
• Product Code: HBE
• UDI-Device Identifier: 07613327294989
• UDI-Public: (01)07613327294989
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/06/2024
• Report Date (Section F): 09/06/2024

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: 5820107530C
• Device Catalogue Number: 5820-107-530C
• Device Lot Number: 24218017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Date Report Sent to FDA: 09/06/2024