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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SAGITTAL SAW ATTACHMENT; ARTHROSCOPE
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SAGITTAL SAW ATTACHMENT; ARTHROSCOPE Back to Search Results
Model Number 4100400000
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2022
Event Type  malfunction  
Event Description
It was reported that the device was getting hotter than usual, and was noticed at the completion of a procedure.The procedure was completed successfully without a clinically significant delay.No adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.
 
Event Description
It was reported that the device was getting hotter than usual, and was noticed at the completion of a procedure.The procedure was completed successfully without a clinically significant delay.No adverse consequences or medical intervention were reported.
 
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Brand Name
SAGITTAL SAW ATTACHMENT
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
colette chung
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key14604788
MDR Text Key293538517
Report Number3015967359-2022-01113
Device Sequence Number1
Product Code HRX
UDI-Device Identifier04546540068323
UDI-Public04546540068323
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number4100400000
Device Catalogue Number4100400000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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