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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POINTER, STRAIGHT K022365

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STRYKER INSTRUMENTS-KALAMAZOO POINTER, STRAIGHT K022365 Back to Search Results
Catalog Number 6007-011-000
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Date 12/14/2015
Event Type  malfunction  
Event Description
It was reported that the tip of the device was bent at the user facility, which could cause a potential inaccuracy. No medical interventions, patient involvement, or adverse consequences were reported with this event.
 
Manufacturer Narrative
The reported event that the tip of the device bent was confirmed through the device inspection. Any physical impact to the pointer, especially with a mallet or similar tool will cause product damage or operational failure due to battery movement.
 
Event Description
It was reported that the tip of the device was bent at the user facility, which could cause a potential inaccuracy. No medical interventions, patient involvement, or adverse consequences were reported with this event.
 
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Brand NamePOINTER, STRAIGHT
Type of DeviceK022365
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5358867
MDR Text Key35611626
Report Number0001811755-2016-00043
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/15/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6007-011-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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