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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORATOR BIT LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACC
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STRYKER INSTRUMENTS-KALAMAZOO PERFORATOR BIT LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACC Back to Search Results
Catalog Number 5100060001
Device Problem Device Abrasion From Instrument Or Another Object (1387)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/17/2014
Event Type  malfunction  
Event Description
It was reported during a procedure the trephine contacted the metal hook.It was further reported that metal cuttings were removed and the procedure was completed successfully.There was no patient impact or adverse consequences reported as a result of this event.
 
Event Description
It was reported during a procedure the trephine contacted the metal hook.It was further reported that metal cuttings were removed and the procedure was completed successfully.There was no patient impact or adverse consequences reported as a result of this event.
 
Manufacturer Narrative
Device not returned to manufacturer.
 
Manufacturer Narrative
The device was not available for return.The quality investigation is complete.Device not returned to manufacturer.
 
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Brand Name
PERFORATOR BIT LARGE 14/11MM
Type of Device
DRILLS, BURRS, TREPHINES & ACC
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
Manufacturer Contact
dervillia murphy
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key3753029
MDR Text Key4392271
Report Number0001811755-2014-01351
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K082010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/20/2014
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 Expiration Date01/01/2015
Device Catalogue Number5100060001
Device Lot Number14029017
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/19/2014
Initial Date FDA Received04/16/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
(B)(4) LOT 13149027
Patient Age55 YR
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