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	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2024
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 5 events were reported for this quarter.Product return status 5 device investigation types have not yet been determined.Additional information 5 devices were not labeled for single-use.5 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 5 malfunction events in which the device was shedding metal debris.- 2 events had no patient involvement; no patient impact.- 3 events had patient involvement; no patient impact.
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: h6, h11.5 previously reported events are included in this follow-up record.Product return status.3 devices were received.1 device was not available for evaluation.1 device investigation type has not yet been determined.
Event or Problem Description
This report summarizes 5 malfunction events in which the device was shedding metal debris.2 events had no patient involvement; no patient impact.3 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 5 previously reported events are included in this follow-up record.Product return status: 4 devices were received.1 device was not available for evaluation.
Event or Problem Description
This report summarizes 5 malfunction events in which the device was shedding metal debris.- 2 events had the problem identified during a non-clinical procedure.There was no patient involvement.- 3 events had patient involvement; no patient impact.

• 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 ; 2693237700
• MDR Report Key: 19820449
• Report Number: 3015967359-2024-01392
• Device Sequence Number: 8679349
• Product Code: HWE
• UDI-Device Identifier: 04546540068354
• UDI-Public: 04546540068354
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 5
• 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): 01/27/2025

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: 4100062000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2024
• Supplement Date Received by Manufacturer: 06/30/2024; 06/30/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/25/2024; 01/27/2025
• 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