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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; DRILLS, BURRS, TREPHINES & ACCESSORIES

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STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Catalog Number UNK_ICO
Device Problem Failure to Auto Stop (2938)
Patient Problem Abrasion (1689)
Event Date 02/22/2018
Event Type  Injury  
Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was an unintentional durotomy during a bur hole as a result of this event.No further information was provided.
 
Manufacturer Narrative
The perforator product reported involved with this event was not returned for evaluation.Without the perforator involved with this event the reported failure of failure to disengage could not be confirmed.Device not returned for evaluation.
 
Event Description
It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was an unintentional durotomy during a bur hole as a result of this event.No further information was provided.
 
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Brand Name
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
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
una barry
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key7366505
MDR Text Key103331975
Report Number0001811755-2018-00533
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_ICO
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/23/2018
Initial Date FDA Received03/23/2018
Supplement Dates Manufacturer Received05/04/2018
Supplement Dates FDA Received05/24/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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