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

Model Number	6203131000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was not labeled for single-use.1 device was reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had patient involvement; no patient impact.
Additional Manufacturer Narrative
Additional information: 1 device was not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 1 malfunction event in which the device or cutting accessory fractured.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: corrected data: h10.1 previously reported event is included in this follow-up record.Product return status: 1 device was not available for evaluation.H3 other text : device not available.
Event or Problem Description
This report summarizes 0 malfunction events in which the device or cutting accessory fractured.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 1 event was previously reported during the reporting period; however, 1 previously reported event in this report should have been included under mfr report # 3015967359-2022-01997.0 previously reported events are included in this follow-up record.Product return status.Additional information: 0 devices were not labeled for single-use.0 devices were not reprocessed or reused.H3 other text : event reported on mfr report # 3015967359-2022-01997.

• Brand Name: 1/4" KEYED CHUCK
• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15663606
• Report Number: 3015967359-2022-01982
• Device Sequence Number: 17766986
• 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: 1
• 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): 01/24/2024

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 Model Number: 6203131000
• Device Catalogue Number: 6203131000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 09/30/2022; 09/30/2022; 09/30/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 01/30/2023; 04/25/2023; 01/24/2024
• 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