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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP HIGH SPEED BUR ATTACHMENT ARTHROSCOPE

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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP HIGH SPEED BUR ATTACHMENT ARTHROSCOPE Back to Search Results
Model Number 4100700000
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Event Description
The user facility reported that the device overheated during testing prior to a procedure. There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand NameHIGH SPEED BUR ATTACHMENT
Type of DeviceARTHROSCOPE
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
zach baker
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key13095438
MDR Text Key282888702
Report Number3015967359-2021-02786
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4100700000
Device Catalogue Number4100700000
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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