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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM RADIOLUCENT DRILL BIT; BIT, SURGICAL
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM RADIOLUCENT DRILL BIT; BIT, SURGICAL Back to Search Results
Model Number 4200355040
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/25/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned.
 
Event Description
It was reported that during a tfna procedure the drill bit broke.It was also reported that a fragment remained in the patient.It was also reported that there was no adverse consequences as a result of this event.It was further reported there was a delay of twenty (20) mins and the procedure was completed successfully.
 
Event Description
It was reported that during a tfna procedure the drill bit broke.It was also reported that a fragment remained in the patient.It was also reported that there was no adverse consequences as a result of this event.It was further reported there was a delay of 20 mins and the procedure was completed successfully.
 
Manufacturer Narrative
H6: the quality investigation is complete.
 
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Brand Name
4.0MM RADIOLUCENT DRILL BIT
Type of Device
BIT, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11636164
MDR Text Key249372769
Report Number3015967359-2021-00366
Device Sequence Number1
Product Code GFG
UDI-Device Identifier04546540217172
UDI-Public04546540217172
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4200355040
Device Catalogue Number4200355040
Device Lot Number20043071
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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