MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1/4" KEYED CHUCK; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	6203131000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
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 device investigation types have not yet been determined.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had a component detach.2 event had no patient involvement; no patient impact.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had a component detach.1 event had no patient involvement; no patient impact.1 event 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: 2 previously reported events are included in this follow-up record.Product return status: 1 device was received.1 device investigation type has not yet been determined.
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, h10 2 previously reported events are included in this follow-up record.Product return status 2 devices were received.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had a component detach.- 2 events had patient involvement; no patient impact.

• Brand Name: 1/4" KEYED CHUCK
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11215948
• Report Number: 0001811755-2021-00292
• Device Sequence Number: 17022230
• Product Code: HWE
• UDI-Device Identifier: 04546540501646
• UDI-Public: 04546540501646
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• 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): 07/29/2021

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
• Operator of Device: No Information
• Device Model Number: 6203131000
• Device Catalogue Number: 6203131000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 12/31/2020; 12/31/2020
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 04/30/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1