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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO THE MILL CABLE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO THE MILL CABLE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 5400704000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Codes No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/27/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during testing at the user facility the device became quite hot.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported.
 
Additional Manufacturer Narrative
H3 other text : device not available for evaluation.
 
Event or Problem Description
It was reported that during testing at the user facility the device became quite hot.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported.
 
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Brand Name
THE MILL CABLE
Common Device Name
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9175622
Report Number0001811755-2019-03207
Device Sequence Number3643208
Product Code HWE
UDI-Device Identifier04546540604132
UDI-Public04546540604132
Combination Product (Y/N)N
Initial Reporter StateRI
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/10/2021
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
Operator of Device Health Professional
Device Model Number5400704000
Device Catalogue Number5400704000
Device Lot Number15336
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/27/2019
Supplement Date Received by Manufacturer09/27/2019
Initial Report FDA Received Date10/10/2019
Supplement Report FDA Received Date06/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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