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

Catalog Number 0206600000

Device Problem Metal Shedding Debris (1804)

Patient Problem No Patient Involvement (2645)

Event Date 07/04/2014

Event Type  malfunction  

Event Description

It was reported that during inspection at the user facility the dual speed cement injection gun was found to be producing metal shavings.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.

Event Description

It was reported that during inspection at the user facility, the dual speed cement injection gun was found to be producing metal shavings.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

A follow up report will be filed after the quality investigation has been completed.

Manufacturer Narrative

The reported event of the device producing metal shavings was confirmed.A possible cause for the device producing metal shavings is burs forming on the teeth of the t-handle rod and catching on the ram bushings.

• Brand Name: DUAL SPEED CEMENT INJECTION 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: 3954603
• MDR Text Key: 4560722
• Report Number: 0001811755-2014-02644
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/04/2014

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: 0206600000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 07/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/1996
• 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