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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP THE MILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP THE MILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 5400700000
Medical Device Problem Code Sparking (2595)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/22/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the device was sparking during testing.No patient involvement was reported.
 
Additional Manufacturer Narrative
Additional information: d9.
 
Event or Problem Description
It was reported that the device was sparking during testing.No patient involvement was reported.
 
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Brand Name
THE MILL
Common Device Name
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12206844
Report Number3015967359-2021-01651
Device Sequence Number4486483
Product Code HWE
UDI-Device Identifier04546540604095
UDI-Public04546540604095
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/06/2021
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 Number5400700000
Device Catalogue Number5400700000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2021
Initial Date Received by Manufacturer 06/22/2021
Supplement Date Received by Manufacturer09/27/2021
Initial Report FDA Received Date07/21/2021
Supplement Report FDA Received Date10/06/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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