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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL LONG STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL LONG STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100015270
Device Problems Break (1069); Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 11/15/2014
Event Type  malfunction  
Event Description
It was reported that during a procure visit it was noticed that a broken bit may be lodged inside of the attachment.There was no associated procedure, surgical delay or adverse consequences reported as a result of this event.
 
Manufacturer Narrative
During the evaluation of the originally listed concomitant device (5100-015-270, lot 08350 - micro drill long straight attachment), it was noted that the components in the device were affected by widespread debris.It is possible that this condition may have caused or contributed to the reported event, as the debris potentially prevented a bur from loading properly and giving the user the impression that a bur was broken off in the device.The associated cutting accessory (unknown ins bur, unknown lot #) is now listed as the concomitant device.
 
Event Description
It was reported that during a procure visit it was noticed that a broken bit may be lodged inside of the attachment.There was no associated procedure, surgical delay or adverse consequences reported as a result of this event.
 
Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.Device not yet returned to the manufacturer.
 
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Brand Name
MICRO DRILL LONG STRAIGHT ATTACHMENT
Type of Device
UNIT, OPERATIVE DENTAL
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
casey metzger
4100 east milham avenue
carrigtwohill bus. & tech park
kalamazoo, MI 49001-NA
2693237700
MDR Report Key4303689
MDR Text Key5507599
Report Number0001811755-2014-04398
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5100015270
Device Lot Number08350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received02/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2009
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
(B)(4) LOT 08350; UNK BUR, LOT UNK
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