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

Model Number	5820107530C
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgery, one of the stryker carbide match head/bur with ref of 5820-107-530c lot# 24193047 got broken and the tip of the bur got recovered but there are some fragments stayed in the body due to its microscopic size, surgeon did x-ray and he's aware of it and decided to close the surgical site because there's no way to remove it.

• Brand Name: N/A
• Common Device Name: DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 20733352
• Report Number: 20733352
• Device Sequence Number: 15688747
• Product Code: HBE
• UDI-Device Identifier: 07613327294989
• UDI-Public: (01)07613327294989
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/19/2024
• Report Date (Section F): 09/19/2024

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: 24193047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2024
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Date Report Sent to FDA: 09/19/2024