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

Catalog Number	8203126000
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 98 events for the failure: flaked.98 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.Reported events: 98 events were reported for this quarter.Product return status: 98 devices were evaluated in the field.Additional information: 98 devices were not labeled for single-use.98 devices were not reprocessed or reused.
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, h11.98 events were originally reported for this failure mode during the reporting quarter; however, - 29 events were inadvertently excluded.- 127 reported events are included in this follow-up record.Product return status: 27 devices had investigation types that have not yet been determined.1 device was received.1 device was not available for evaluation.98 devices were evaluated in the field.Additional information: 127 devices were not labeled for single-use.127 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 127 events for the failure: flaked.- 127 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 # 3015967359-2025-99011.Supplemental rationale, corrected data: b5, h1, h6, h11.127 events were originally reported for this failure mode during the reporting quarter: however, - 7 events were reported in error.- 11 previously reported events in this report should have been included under mfr report # 3015967359-2025-99013.- 109 reported events are included in this follow-up record.Product return status.108 devices were evaluated in the field.1 device was not available for evaluation.Evaluation findings (results/components).108 devices: material and/or chemical problem identified / coating material.1 device: no findings available / part/component/sub-assembly term not applicable.Product disposition.108 devices: scrapped by stryker.1 device: product not received.
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 109 events for the failure: flaked.- 108 events had problem identified during non-clinical procedure; there was no patient involvement.- 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 108 events for the failure: flaked.108 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 # 3015967359-2025-99011.Supplemental rationale corrected data: b5, h1, h6, h11.109 events were previously reported during the reporting quarter; however, 1 event was reported in error.108 previously reported events are included in this follow-up record.Product return status: 108 devices were evaluated in the field.Evaluation findings (results/components): 108 devices: material and/or chemical problem identified / coating material.Product disposition: 108 devices: scrapped by stryker.

• Brand Name: DUAL TRIGGER PIN 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: 22586835
• Report Number: 3015967359-2025-99011
• Device Sequence Number: 4502103
• Product Code: HWE
• UDI-Device Identifier: 07613327304558
• UDI-Public: 07613327304558
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 108
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/29/2026

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: 8203126000
• 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; 06/30/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 07/31/2025; 10/31/2025; 01/29/2026
• 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