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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REMB ELECTRIC RECIPROCATING SAW; ARTHROSCOPE

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STRYKER INSTRUMENTS-KALAMAZOO REMB ELECTRIC RECIPROCATING SAW; ARTHROSCOPE Back to Search Results
Model Number 6400037000
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2022
Event Type  malfunction  
Event Description
The manufacturer service technician reported that the device overheated while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
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Brand Name
REMB ELECTRIC RECIPROCATING SAW
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
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 Key14193071
MDR Text Key289967140
Report Number3015967359-2022-00737
Device Sequence Number1
Product Code HRX
UDI-Device Identifier07613154938339
UDI-Public07613154938339
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 Other
Type of Report Initial
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6400037000
Device Catalogue Number6400037000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2022
Initial Date Manufacturer Received 04/09/2022
Initial Date FDA Received04/25/2022
Was Device Evaluated by Manufacturer? Yes
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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