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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (13.0X1.27X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (13.0X1.27X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL Back to Search Results
Catalog Number 6113127090
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/29/2018
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Blade was discarded.
 
Event Description
It was reported that during a tka (total knee arthroplasty) procedure, the blade broke.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
 
Event Description
It was reported that during a tka (total knee arthroplasty) procedure, the blade broke.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
 
Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.Blade was discarded.
 
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Brand Name
PERFORMANCE SERIES SAGITTAL BLADE (13.0X1.27X90MM)
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8181771
MDR Text Key131004221
Report Number0001811755-2018-02850
Device Sequence Number1
Product Code GFA
UDI-Device Identifier04546540501356
UDI-Public04546540501356
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 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2023
Device Catalogue Number6113127090
Device Lot Number18227017
Was Device Available for Evaluation? No
Date Manufacturer Received02/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
6208000000 SN (B)(4)
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