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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO IRRIGATION HIGH FLOW TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO IRRIGATION HIGH FLOW TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210015000
Device Problems Disassembly (1168); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2015
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure at the user facility, the tip of the device fractured and disassembled.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Device has not yet been returned for analysis.
 
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Brand Name
IRRIGATION HIGH FLOW TIP
Type of Device
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
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 Key4919401
MDR Text Key19306902
Report Number0001811755-2015-02588
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUS
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 06/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0210015000
Device Lot Number14290012
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/22/2015
Initial Date FDA Received07/16/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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