MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE 14CM STRAIGHT ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5407120480
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 142 events were reported for this quarter.Product return status: 141 devices were evaluated based on historical data analysis.1 device investigation type has not yet been determined.Additional information: 142 devices were not labeled for single-use.142 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 142 malfunction events in which the device reportedly overheated.115 events had the problem identified during a non-clinical procedure; there was no patient involvement.4 events had the problem identified before clinical use/exposure; there was no patient involvement.22 events had patient involvement: no patient 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, h11.142 previously reported events are included in this follow-up record.Product return status: 142 devices were evaluated based on historical data analysis.
Event or Problem Description
This report summarizes 142 malfunction events in which the device reportedly overheated.- 115 events had the problem identified during a non-clinical procedure; there was no patient involvement.- 4 events had the problem identified before clinical use/exposure; there was no patient involvement.-22 events had patient involvement; no patient impact.- 1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.

• Brand Name: ELITE 14CM STRAIGHT 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: 21207558
• Report Number: 3015967359-2025-00284
• Device Sequence Number: 3810316
• Product Code: HBE
• UDI-Device Identifier: 07613327096583
• UDI-Public: 07613327096583
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 142
• 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): 04/23/2025

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: 5407120480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 04/23/2025
• 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