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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CORDLESS DRIVER 3 HANDPIECE; MB POWER TOOLS
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CORDLESS DRIVER 3 HANDPIECE; MB POWER TOOLS Back to Search Results
Model Number 4300000000
Medical Device Problem Code Fail-Safe Problem (2936)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/18/2021
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer service technician reported that the safety bar was stuck in run mode, no run-on was observed, while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
Update: d9, h3, h6: device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The manufacturer service technician reported that the safety bar was stuck in run mode, no run-on was observed, while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
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Brand Name
CORDLESS DRIVER 3 HANDPIECE
Common Device Name
MB POWER TOOLS
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12449163
Report Number3015967359-2021-01979
Device Sequence Number4381625
Product Code HRX
UDI-Device Identifier07613154641284
UDI-Public07613154641284
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 09/29/2021
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 No Information
Device Model Number4300000000
Device Catalogue Number4300000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2021
Initial Date Received by Manufacturer 08/18/2021
Supplement Date Received by Manufacturer09/29/2021
Initial Report FDA Received Date09/09/2021
Supplement Report FDA Received Date09/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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