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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 & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO PERFORATOR BIT LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES 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 available for return to manufacturer.
 
Manufacturer Narrative
The device was not made 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 & ACCESSORIES
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 Key3753032
MDR Text Key4405508
Report Number0001811755-2014-01352
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
Date FDA Received04/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2014
Device Catalogue Number5100060001
Device Lot Number13149027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/19/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/29/2013
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 14029017
Patient Age55 YR
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