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

Catalog Number 0606600000

Device Problems Disassembly (1168); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Event Description

It was reported that during testing, the screw fell out at the end of the device.There was no associated procedure and therefore, no patient involvement or adverse consequences reported.

Manufacturer Narrative

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

Event Description

It was reported that during testing, the screw fell out at the end of the device.There was no associated procedure and therefore, no patient involvement or adverse consequences reported.

• Brand Name: REVOLUTION 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: 7500522
• MDR Text Key: 107822273
• Report Number: 0001811755-2018-00969
• Device Sequence Number: 1
• Product Code: JDZ
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0606600000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1