MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP DUAL SPEED CEMENT INJECTION GUN; MIXER, CEMENT, FOR CLINICAL USE

Model Number	0206600000
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
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: 4 events were reported for this quarter.Product return status: 4 device investigation types have not yet been determined.Additional information: 4 devices were not labeled for single-use.4 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 4 malfunction events in which the device was shedding metal debris.4 events had no patient involvement; no patient impact.
Event or Problem Description
This report summarizes 4 malfunction events in which the device was shedding metal debris.1 event 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: 4 previously reported events are included in this follow-up record.Product return status: 1 device was received.2 devices were not available for evaluation.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, h10.4 previously reported events are included in this follow-up record.Product return status: 2 devices were received.2 devices were not available for evaluation.
Event or Problem Description
This report summarizes 4 malfunction events in which the device was shedding metal debris.Events had patient involvement; no patient impact.

• Brand Name: DUAL SPEED CEMENT INJECTION GUN
• Common Device Name: MIXER, CEMENT, FOR CLINICAL USE
• 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: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12680282
• Report Number: 3015967359-2021-02348
• Device Sequence Number: 4238400
• Product Code: JDZ
• UDI-Device Identifier: 04546540039620
• UDI-Public: 04546540039620
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 4
• 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): 04/11/2022

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: 0206600000
• Device Catalogue Number: 0206600000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021; 09/30/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 01/20/2022; 04/11/2022
• 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