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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 No Consequences Or Impact To Patient (2199)
Event Date 09/04/2018
Event Type  malfunction  
Manufacturer Narrative
Awaiting device evaluation.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 continued to run on longer than expected.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery 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.The (b)(4) rev.F provides instructions on how to test the disengagement function of the perforator prior to use.The event did not involve a product problem indicating a non-conformity or unanticipated hazard.No further action is required at this time.
 
Event Description
It was reported that during a cranial procedure, the perforator continued to run on longer than expected.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery 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
MDR Report Key7912791
MDR Text Key122105566
Report Number0001811755-2018-01679
Device Sequence Number1
Product Code HBF
UDI-Device Identifier04546540716224
UDI-Public04546540716224
Combination Product (y/n)N
PMA/PMN Number
K082010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/01/2021
Device Catalogue Number5100060001
Device Lot Number18082037
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2018
Date Manufacturer Received11/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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