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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-PUERTO RICO 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 Therapeutic Effects, Unexpected (2099)
Event Date 04/25/2014
Event Type  Injury  
Event Description
It was reported that during a procedure the cartridge from the advanced cement mixing bowl and 180-gram cement cartridge (acm) broke during injection, which resulted in an hour and a half delay in the procedure.It could not be confirmed whether or not additional anesthesia was required.The procedure was completed successfully utilizing back-up equipment.No medical intervention was reported with this event.
 
Manufacturer Narrative
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.The device was discarded by the manufacturer.
 
Event Description
It was reported that during a procedure the cartridge from the advanced cement mixing bowl and 180-gram cement cartridge (acm) broke during injection, which resulted in an hour and a half delay in the procedure.It could not be confirmed whether or not additional anesthesia was required.The procedure was completed successfully utilizing back-up equipment.No medical intervention was 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-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 Key3824903
MDR Text Key4686011
Report Number0001811755-2014-01854
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
Report Date 04/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0306563000
Device Lot Number13324012 OR 13350012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/31/2014
Initial Date FDA Received05/21/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/03/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age82 YR
Patient Weight45
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