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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 03/12/2019
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting product return to manufacturer.
 
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.
 
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 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 quality investigation is complete.
 
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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 Key8478808
MDR Text Key140781761
Report Number0001811755-2019-01082
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 06/04/2019
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 03/12/2019
Initial Date FDA Received04/03/2019
Supplement Dates Manufacturer Received05/28/2019
Supplement Dates FDA Received06/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
5400210060 S/N, (B)(4); 5400210060 S/N, (B)(4)
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