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

Model Number 0606600000

Device Problem Material Disintegration (1177)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 11 events were reported for this quarter.Product return status: 11 device investigation types have not yet been determined.11 devices were not labeled for single-use.11 devices were not reprocessed or reused.

Event Description

This report summarizes 11 malfunction events in which the device was shedding metal debris.11 events had no patient involvement; no patient impact.

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 11 previously reported events are included in this follow-up record.Product return status 1 device was received.10 device investigation types have not yet been determined.

Event Description

This report summarizes 11 malfunction events in which the device was shedding metal debris.- 11 events had no patient involvement; no patient impact.

Event Description

This report summarizes 11 malfunction events in which the device was shedding metal debris.- 11 events had no patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 11 previously reported events are included in this follow-up record.Product return status: 10 devices were received.1 device investigation type has not yet been determined.

Event Description

This report summarizes 11 malfunction events in which the device was shedding metal debris.10 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 11 previously reported events are included in this follow-up record.Product return status: 10 devices were received.1 device was not available for evaluation.

• Brand Name: REVOLUTION CEMENT GUN
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 10748323
• MDR Text Key: 213467575
• Report Number: 0001811755-2020-02807
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 04546540437037
• UDI-Public: 04546540437037
• Combination Product (y/n): N
• Number of Events Reported: 11
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0606600000
• Device Catalogue Number: 0606600000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1