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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZYPHR DISPOSABLE CRANIAL PERFORATOR, LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO ZYPHR DISPOSABLE CRANIAL PERFORATOR, LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Catalog Number 5100060001
Device Problem Failure to Auto Stop (2938)
Patient Problem Abrasion (1689)
Event Date 05/09/2018
Event Type  Injury  
Manufacturer Narrative
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.It was further reported that there were no surgical delay and the procedure was completed successfully.
 
Manufacturer Narrative
The perforator product reported involved with this event was returned for evaluation and the disengagement mechanism within the perforator was tested and functioned as intended.The reported failure of failure to disengage could not be confirmed.
 
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.It was further reported that there were no surgical delay and the procedure was completed successfully.
 
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Brand Name
ZYPHR DISPOSABLE CRANIAL PERFORATOR, 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
derek lane
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key7548624
MDR Text Key109374154
Report Number0001811755-2018-01016
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K082010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/27/2018
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 Number5100060001
Device Lot Number18072027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/09/2018
Initial Date FDA Received05/29/2018
Supplement Dates Manufacturer Received07/27/2018
Supplement Dates FDA Received07/27/2018
Was Device Evaluated by Manufacturer? Yes
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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