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 11/08/2013

Event Type  malfunction  

Event Description

It was reported that during a hemi-arthroplasy procedure the advanced cement mixing bowl and 180-gram cement cartridge disassembled.It was reported that the wound was irrigated by the physician.Several attempts were made to obtain additional information from the user facility; however, no additional information was provided.If additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

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

• 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: 3647173
• MDR Text Key: 4199613
• Report Number: 0001811755-2014-00610
• 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
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0306563000
• Device Lot Number: 13240012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2013
• 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