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 Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 148 malfunction events in which the device reportedly overheated.127 events had no patient involvement; no patient impact.18 events had patient involvement; no patient impact.2 events had insufficient information received.1 event had a minor injury/illness/impairment leading to a 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: 148 events were reported for this quarter.Product return status: 5 devices were received.1 device was not available for evaluation.137 devices were evaluated based on historical data analysis.5 device investigation types have not yet been determined.Additional information: 148 devices were not labeled for single-use.148 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 148 malfunction events in which the device reportedly overheated.- 127 events had the problem identified during a non-clinical procedure; there was no patient involvement.- 18 events had patient involvement; no patient impact.- 2 events had insufficient information received regarding health impact.- 1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
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 148 previously reported events are included in this follow-up record.Product return status 5 devices were received.2 devices were not available for evaluation.141 devices were evaluated based on historical data analysis.

• 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: 20499874
• Report Number: 3015967359-2024-01975
• Device Sequence Number: 20641945
• 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: 148
• 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: 10/21/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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