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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0306563000
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2014
Event Type  malfunction  
Event Description
It was reported that during a procedure the advanced cement mixing bowl cartridge broke.It was reported 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 reported failure condition (cartridge breakage) was confirmed upon evaluation of the returned cartridge component.The breakage occurred at the proximal end (base) of the cartridge, where it connects to the cement injection gun.A definite root cause could not be determined.The device was scrapped at the manufacturer.
 
Event Description
It was reported that during a procedure, the advanced cement mixing bowl cartridge broke.It was reported 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 was discarded by the manufacturer.
 
Event Description
It was reported that during a procedure the advanced cement mixing bowl cartridge broke.It was reported 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
A follow up report will be filed after the quality investigation has been completed.
 
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Brand Name
ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE
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-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 Key4036522
MDR Text Key15998634
Report Number0001811755-2014-03021
Device Sequence Number1
Product Code JDZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 08/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0306563000
Device Lot Number14112012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/04/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
DUAL SPEED CEMENT GUN (B)(4) (UNKNOWN)
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