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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO COAXIAL FEMORAL CANAL TIP; LAVAGE, JET

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STRYKER INSTRUMENTS-PUERTO RICO COAXIAL FEMORAL CANAL TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210007000
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2017
Event Type  malfunction  
Manufacturer Narrative
Customer discarded.
 
Event Description
The user facility reported that the tip cracked at the connection point of the handpiece during a procedure.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
COAXIAL FEMORAL CANAL TIP
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 Key6585361
MDR Text Key75774690
Report Number0001811755-2017-01249
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0210007000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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