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

Model Number 0606100000

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/31/2022

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: 2 events were reported for this quarter.Product return status: 1 device was received.1 device investigation type has not yet been determined.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.

Event 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.

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 2 devices were received.

Event 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: REVOLUTION FRICTION 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
• 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: 14193689
• MDR Text Key: 289988912
• Report Number: 3015967359-2022-00890
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 07613154259793
• UDI-Public: 07613154259793
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0606100000
• Device Catalogue Number: 0606100000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1