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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SAGITTAL SAW ATTACHMENT; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO SAGITTAL SAW ATTACHMENT; ARTHROSCOPE Back to Search Results
Model Number 4100400000
Device Problem Overheating of Device (1437)
Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2020
Event Type  malfunction  
Event Description
The user facility reported that the device overheated during a procedure.  the patient received a small 0.5 cm burn from the attachment.Small blister present post-op that was treated by changing the dressing with no sign of infection one week later.No medical intervention or adverse consequences were reported.
 
Event Description
The user facility reported that the device overheated during a procedure.  the patient received a small 0.5 cm burn from the attachment.Small blister present post-op that was treated by changing the dressing with no sign of infection one week later.No medical intervention or adverse consequences were reported.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
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Brand Name
SAGITTAL SAW ATTACHMENT
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10951270
MDR Text Key219762898
Report Number0001811755-2020-03353
Device Sequence Number1
Product Code HRX
UDI-Device Identifier04546540068323
UDI-Public04546540068323
Combination Product (y/n)N
PMA/PMN Number
K112593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4100400000
Device Catalogue Number4100400000
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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