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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZYPHR PERFORATOR BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO ZYPHR PERFORATOR BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Catalog Number 5100060001
Device Problem Failure to Auto Stop (2938)
Patient Problem No Patient Involvement (2645)
Event Date 10/11/2019
Event Type  malfunction  
Manufacturer Narrative
The reported event, for perforator bit failure to disengage, was not confirmed as the perforator bit was not returned for evaluation.Without the perforator bit, the root cause cannot be determined.A device history record (dhr) review was not possible in this event as the lot number was reported as unknown.The ifu #5100-060-700 rev.F provides instructions on how to test the disengagement function of the perforator prior to use.The ifu also warns: use extreme caution when drilling in conditions such as: bone that may vary in consistency and/or thickness greater than 1 mm, adherent dura, high intracranial pressure, other abnormalities in the area of penetration.The perforator may cut or nick the dura or brain.Device discarded by customer.
 
Event Description
It was reported that during testing, the perforator continued to run on longer than expected.It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement, no delay and no adverse consequences as a result of this event.
 
Event Description
It was reported that during testing, the perforator continued to run on longer than expected.It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement, no delay and no adverse consequences as a result of this event.
 
Manufacturer Narrative
The reported event, for perforator bit failure to disengage, was not confirmed as the perforator bit was not returned for evaluation.Without the perforator bit, the root cause cannot be determined.The ifu #5100-060-700 rev.F provides instructions on how to test the disengagement function of the perforator prior to use.The ifu also warns: use extreme caution when drilling in conditions such as: ¿ bone that may vary in consistency and/or thickness greater than 1 mm ¿ adherent dura ¿ high intracranial pressure ¿ other abnormalities in the area of penetration the perforator may cut or nick the dura or brain.Device discarded by customer.
 
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Brand Name
ZYPHR PERFORATOR BIT
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9318127
MDR Text Key166426908
Report Number0001811755-2019-03736
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 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100060001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/06/2019
Initial Date FDA Received11/13/2019
Supplement Dates Manufacturer Received11/11/2019
Supplement Dates FDA Received11/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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