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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO DUAL SPIKE ADAPTER; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO DUAL SPIKE ADAPTER; LAVAGE, JET Back to Search Results
Catalog Number 0203030000
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2015
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure at the user facility foreign material was found in the sterile packaging of the product.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Device is still in transit to manufacturer for failure analysis.
 
Manufacturer Narrative
The device was scrapped by stryker.
 
Event Description
It was reported that during a surgical procedure at the user facility foreign material was found in the sterile packaging of the product.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand Name
DUAL SPIKE ADAPTER
Type of Device
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key4917688
MDR Text Key6054089
Report Number0001811755-2015-02574
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0203030000
Device Lot Number15068012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received08/04/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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