MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP DUAL TRIGGER LARGE COLLET; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	8203226000
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	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 14 events were reported for this quarter.Product return status 14 devices were evaluated in the field.Additional information 14 devices were not labeled for single-use.14 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 14 events for the failure: flaked.- 14 events had problem identified during non-clinical procedure; there was no patient involvement.
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, h1, h6, h11 14 events were originally reported for this failure mode during the reporting quarter; however, - 13 events were inadvertently excluded.- 27 reported events are included in this follow-up record.Product return status 13 devices had investigation types that have not yet been determined.14 devices were evaluated in the field.Additional information 27 devices were not labeled for single-use.27 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 27 events for the failure: flaked.- 27 events had problem identified during non-clinical procedure; there was no patient involvement.
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 24 events for the failure: flaked.24 events had problem identified during non-clinical procedure; there was no patient involvement.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99012.Supplemental rationale: corrected data: b5, h1, h6, h11.27 events were previously reported during the reporting quarter: however, 3 events were reported in error.- 24 previously reported events are included in this follow-up record.Product return status: 24 devices were evaluated in the field.Evaluation findings (results/components): 24 devices: material and/or chemical problem identified / coating material.Product disposition: 24 devices: scrapped by stryker.

• Brand Name: DUAL TRIGGER LARGE 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 ; 2693237700
• MDR Report Key: 22586857
• Report Number: 3015967359-2025-99012
• Device Sequence Number: 18462227
• Product Code: HWE
• UDI-Device Identifier: 07613327304442
• UDI-Public: 07613327304442
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 24
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2025

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: 8203226000
• 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; 06/30/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 07/31/2025; 10/31/2025
• 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