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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X100MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X100MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2022
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting for device return to manufacturer.
 
Event Description
It was reported that during a surgical procedure the blade was not cutting as expected and broke.It was also reported there were no adverse consequences as a result of this event.It was further reported that the event caused a delay of unknown duration.It was further reported that the procedure was completed successfully.No further information was provided.
 
Event Description
It was reported that during a surgical procedure the blade was not cutting as expected and broke.It was also reported there were no adverse consequences as a result of this event.It was further reported that the event caused a delay of unknown duration.It was further reported that the procedure was completed successfully.No further information was provided.
 
Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : historical data, known and understood failure.
 
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Brand Name
PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X100MM)
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY,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 Key16033900
MDR Text Key307585455
Report Number3015967359-2022-02483
Device Sequence Number1
Product Code GFA
UDI-Device Identifier00885825015947
UDI-Public00885825015947
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number6118127100
Device Lot Number22230027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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