MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE 12CM ANGLED ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5407120472
Medical Device Problem Codes	Fluid/Blood Leak (1250); Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 1 malfunction event in which the device reportedly overheated and was leaking.1 event had a minor injury, illness, or impairment leading to hospitalization or prolonged hospitalization.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 1 event was reported for this quarter.Product return status 1 device investigation type has not yet been determined.Additional information 1 device was not labeled for single-use.1 device was not reprocessed or reused.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h6, h11 1 previously reported event is included in this follow-up record.Product return status 1 device was not available for evaluation.
Event or Problem Description
This report summarizes 1 malfunction event in which the device reportedly overheated and was leaking.- 1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.

• Brand Name: ELITE 12CM ANGLED ATTACHMENT
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20501704
• Report Number: 3015967359-2024-02160
• Device Sequence Number: 7608131
• Product Code: HBE
• UDI-Device Identifier: 07613327096576
• UDI-Public: 07613327096576
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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 Catalogue Number: 5407120472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown