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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.5MM RADIOLUCENT DRILL BIT; BIT, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO 3.5MM RADIOLUCENT DRILL BIT; BIT, SURGICAL Back to Search Results
Model Number 4200355035
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
 
Event Description
It was reported during a surgical procedure that there was a potential sterility breach on the packaging of the device.It was also reported that there was no adverse consequences and no delays as a result of this event and the procedure was completed successfully.
 
Manufacturer Narrative
H6: the quality investigation is complete.
 
Event Description
It was reported during a surgical procedure that there was a potential sterility breach on the packaging of the device.It was also reported that there was no adverse consequences and no delays as a result of this event and the procedure was completed successfully.
 
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Brand Name
3.5MM RADIOLUCENT DRILL BIT
Type of Device
BIT, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9950052
MDR Text Key187260854
Report Number0001811755-2020-00900
Device Sequence Number1
Product Code GFG
UDI-Device Identifier04546540217165
UDI-Public04546540217165
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4200355035
Device Catalogue Number4200355035
Device Lot Number19344017
Was Device Available for Evaluation? No
Date Manufacturer Received05/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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