MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number 0306563000

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure the cartridge from the advanced cement mixing bowl and 180-gram cement cartridge broke while injecting the cement.It was reported that nothing fell into the surgical site and that the procedure was completed successfully utilizing back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device will not be returned as it was discarded by the user facility; it is not possible to determine the cause of the reported malfunction without an evaluation of the device.

• Brand Name: ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3735852
• MDR Text Key: 21732094
• Report Number: 0001811755-2014-01231
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0306563000
• Device Lot Number: 13296012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1