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 02/20/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure the advanced cement mixing syringe disassembled.The procedure was completed successfully by hand.No delay, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported that during a procedure the advanced cement mixing syringe disassembled.The procedure was completed successfully by hand.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

A third dual speed cement injection gun was added per additional information.The reported failure condition was confirmed upon evaluation of the returned cartridge component.The breakage occurred at the proximal end of the cartridge, where it connects to the cement injection gun.Some voids were observed on the breakage area.The device was discarded by the manufacturer.

• 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: 3685681
• MDR Text Key: 4301167
• Report Number: 0001811755-2014-00931
• 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,Followup
• Report Date: 02/20/2014

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: 0306563000
• Device Lot Number: 13296012/133274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 03/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2013
• 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
• Treatment: CEMENT INJECTION GUN 0206600000 (0513300693); CEMENT INJECTION GUN 0206600000 (0527909513); DUAL SPEED CEMENT GUN 0206600000 (0527909513)