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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO FEMORAL CANAL TIP, IRRIGATION/SUCTION; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO FEMORAL CANAL TIP, IRRIGATION/SUCTION; LAVAGE, JET Back to Search Results
Catalog Number 0210008000
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2017
Event Type  malfunction  
Manufacturer Narrative
Device was discarded.
 
Event Description
The user facility reported that the device's tip broke in the patient's bone marrow during a procedure.The tip was removed with no additional cutting to the patient.There was no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
FEMORAL CANAL TIP, IRRIGATION/SUCTION
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-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6555455
MDR Text Key74774144
Report Number0001811755-2017-01232
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0210008000
Device Lot Number16264012
Was Device Available for Evaluation? No
Date Manufacturer Received04/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2016
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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