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

Catalog Number 0606600000

Device Problem Disassembly (1168)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 03/19/2014

Event Type  malfunction  

Event Description

It was reported that in central sterile at the user facility, a screw was found to be missing from the distal end of the revolution cement gun.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

Update due to additional information received from the user facility.

Event Description

It was reported that at the user facility a screw was found to be missing from the distal end of the revolution cement gun.No further information was provided by the user facility.

Manufacturer Narrative

Upon visual inspection, the back pawl was found to be worn.The device was repaired and returned to the user facility.

• 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3746112
• MDR Text Key: 20299088
• Report Number: 0001811755-2014-01289
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 0606600000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 04/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2005
• 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