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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.2MM RADIOLUCENT DRILL BIT; BIT, SURGICAL
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.2MM RADIOLUCENT DRILL BIT; BIT, SURGICAL Back to Search Results
Model Number 4200355042
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2022
Event Type  Injury  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
 
Event Description
It was reported that during a surgical procedure, it was noted that the drill bit broke.It was also reported that the fractured tip of the drill bit was still stuck in the bone.It was further reported that the bone was shaved around the drill tip so the fragment could be removed successfully.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
 
Event Description
It was reported that during a surgical procedure, it was noted that the drill bit broke.It was also reported that the fractured tip of the drill bit was still stuck in the bone.It was further reported that the bone was shaved around the drill tip so the fragment could be removed successfully.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
 
Manufacturer Narrative
The quality investigation is complete.
 
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Brand Name
4.2MM RADIOLUCENT DRILL BIT
Type of Device
BIT, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
Manufacturer Contact
una barry
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
214532900
MDR Report Key14938705
MDR Text Key295398644
Report Number3015967359-2022-01260
Device Sequence Number1
Product Code GFG
UDI-Device Identifier04546540348593
UDI-Public04546540348593
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2023
Device Model Number4200355042
Device Catalogue Number4200355042
Device Lot Number20143017
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received08/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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