MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MIS 13CM MODIFIED CURVED; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5407120950F
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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: 7 events were reported for this quarter.Product return status: 7 devices had investigation types that have not yet been determined.Additional information: 7 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 7 events for the failure: overheating of device.3 events had problem identified before clinical use/exposure; there was no patient involvement.3 events had no health consequences or impact.1 event had insufficient information.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between april 1 ¿ june 30 2025.This report summarizes 6 events for the failure: overheating of device.- 3 events had problem identified before clinical use/exposure; there was no patient involvement.- 3 events had no health consequences or impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99245.Supplemental rationale corrected data: b5, h1, h6, h11.7 events were previously reported during the reporting period: however, - 1 previously reported event in this report should have been included under mfr report # 3015967359-2025-99538.- 6 previously reported events are included in this follow-up record.Product return status: 6 devices were evaluated based on historical data analysis.Evaluation findings (results/components).6 devices: degradation problem identified, wear problem, lubrication problem identified, overheating problem identified / part/component/sub-assembly term not applicable.Product disposition: 6 devices: product not received.

• Brand Name: MIS 13CM MODIFIED CURVED
• 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: 22648107
• Report Number: 3015967359-2025-99245
• Device Sequence Number: 20984943
• Product Code: HBE
• UDI-Device Identifier: 07613327402247
• UDI-Public: 07613327402247
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 6
• 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): 10/31/2025

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: 5407120950F
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/31/2025
• 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