MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION FRICTION CEMENT GUN; MIXER, CEMENT, FOR CLINICAL USE

Model Number 0606100000

Device Problem Flaked (1246)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 03/27/2019

Event Type  malfunction  

Event Description

It was reported that during use paint was chipping off the device.The procedure was successfully completed and there was no patient impact.

Event Description

It was reported that during use paint was chipping off the device.The procedure was successfully completed and there was no patient impact.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: REVOLUTION FRICTION CEMENT GUN
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8544456
• MDR Text Key: 142906252
• Report Number: 0001811755-2019-01294
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 07613154259793
• UDI-Public: 07613154259793
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0606100000
• Device Catalogue Number: 0606100000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1