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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3IN 19G STRAIGHT DEKOMPRESSOR PERCUTANEOUS DISCECTOMY KIT ARTHROSCOPE

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STRYKER INSTRUMENTS-KALAMAZOO 3IN 19G STRAIGHT DEKOMPRESSOR PERCUTANEOUS DISCECTOMY KIT ARTHROSCOPE Back to Search Results
Catalog Number 0407281000
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/17/2018
Event Type  Injury  
Event Description
It was reported that during a procedure, the probe broke off inside of the patient. The procedure was not successfully completed as medical intervention was necessary to remove the device material. No additional adverse consequences were reported.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that during a procedure, the probe broke off inside of the patient. The procedure was not successfully completed as medical intervention was necessary to remove the device material. No additional adverse consequences were reported.
 
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Brand Name3IN 19G STRAIGHT DEKOMPRESSOR PERCUTANEOUS DISCECTOMY KIT
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo MI 00615
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key8071656
MDR Text Key127200329
Report Number0001811755-2018-02468
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0407281000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2018
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

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