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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 6? 17 GAUGE CURVED DEKOMPRESSOR PERCUTANEOUS DISCECTOMY KIT ARTHROSCOPE

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STRYKER INSTRUMENTS-KALAMAZOO 6? 17 GAUGE CURVED DEKOMPRESSOR PERCUTANEOUS DISCECTOMY KIT ARTHROSCOPE Back to Search Results
Catalog Number 0407251000
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/08/2018
Event Type  malfunction  
Event Description
It was reported that during a procedure, the probe broke off inside of the patient. The device material was removed from the patient without further adverse consequences. There was no clinically significant medical delay and the procedure was successfully completed.
 
Event Description
It was reported that during a procedure, the probe broke off inside of the patient. The device material was removed from the patient without further adverse consequences. There was no clinically significant medical delay and the procedure was successfully completed.
 
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Brand Name6? 17 GAUGE CURVED 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-KALAMAZOO
4100 east milham avenue
highway #3, km 130.2
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7346786
MDR Text Key102731561
Report Number0001811755-2018-00523
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K032473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0407251000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2018
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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