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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MAESTRO STRAIGHT M ATTACHMENT; MOTOR, DRILL, PNEUMATIC
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STRYKER INSTRUMENTS-KALAMAZOO MAESTRO STRAIGHT M ATTACHMENT; MOTOR, DRILL, PNEUMATIC Back to Search Results
Catalog Number 5400210050
Device Problems Break (1069); Corroded (1131)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/07/2014
Event Type  malfunction  
Event Description
It was reported that the bur got stuck in the attachment.Upon repair by the manufacturer a broken bur was found inside of the attachment.It was further reported that there was no surgical delay or adverse consequences as a result of this event.
 
Manufacturer Narrative
The cutting accessory originally reported under this mdr was returned, the returned device was confirmed to be broken along the shank.During the evaluation of the originally listed concomitant device ((b)(4)lot 1233205203 maestro straight m attachment) it was found the attachment had corroded internal components.Corrosion of the internal components can cause increased friction binding between the bur and the attachment shaft.This can cause the bur to break.Associated cutting accessories (unknown ins bur) is now listed as the concomitant device.
 
Event Description
It was reported that the bur got stuck in the attachment.Upon repair by the manufacturer a broken bur was found inside of the attachment.It was further reported that there was no surgical delay or adverse consequences as a result of this event.
 
Manufacturer Narrative
Device not yet returned to the manufacturer.
 
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Brand Name
MAESTRO STRAIGHT M ATTACHMENT
Type of Device
MOTOR, DRILL, PNEUMATIC
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
carrigtwohill bus. & tech park
kalamazoo MI 49001 NA
Manufacturer Contact
dervillia murphy
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key3957182
MDR Text Key4978876
Report Number0001811755-2014-02674
Device Sequence Number1
Product Code HBB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5400210050
Device Lot Number1233205203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received10/03/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNK INS BUR, UNK LOT #; (B)(4) LOT 1233205203
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