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 Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2019
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 was shedding metal debris.2 events had no 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: b5, h10.2 events were previously reported in this record during the reporting period; however, - 1 previously reported event in this report was determined to be a duplicate of the other event reported in this record.- 1 previously reported event is included in this follow-up record.Product return status.1 device investigation type has not yet been determined.
Event or Problem Description
This report summarizes 1 malfunction event in which the device was shedding metal debris.1 event had no patient involvement; no patient impact.
Event or Problem Description
This report summarizes 1 malfunction event in which the device was shedding metal debris.1 event had no 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: 1 previously reported event is included in this follow-up record.Product return status: 1 device was received.

• 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
• MDR Report Key: 9636502
• Report Number: 0001811755-2020-00176
• Device Sequence Number: 13541624
• 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: 1
• 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): 04/29/2021

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: 0206600000
• Device Catalogue Number: 0206600000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 12/31/2019
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 07/31/2020; 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1