MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp WIRE COLLET; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Catalog Number	4100062000
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: 2 events were reported for this quarter.Product return status: 2 devices had investigation types that have not yet been determined.Evaluation findings (results/components): 2 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition: 2 devices: product disposition is not yet determined.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.
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 january 1 ¿ march 31, 2026.This report summarizes 2 events for the failure: overheating of device.1 event had insufficient information.1 event had problem identified during non-clinical procedure; there was no patient involvement.

• Brand Name: WIRE COLLET
• Common Device Name: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
• 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 ; +1(269)323-7700
• MDR Report Key: 24954413
• Report Number: 3015967359-2026-99307
• Device Sequence Number: 20153040
• Product Code: HWE
• UDI-Device Identifier: 04546540068354
• UDI-Public: 04546540068354
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 4100062000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 09/16/2026
• 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