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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PI DRIVE MOTOR; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PI DRIVE MOTOR; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5407100000
Medical Device Problem Code Component Missing (2306)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/07/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: report submitted to document device evaluation results.
 
Event or Problem Description
It was reported that the ball collar on the device was missing by the manufacturer service technician.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand Name
PI DRIVE MOTOR
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12481596
Report Number3015967359-2021-02017
Device Sequence Number20018485
Product Code ERL
UDI-Device Identifier07613327096378
UDI-Public07613327096378
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K141935
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/16/2021
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 Number5407100000
Device Catalogue Number5407100000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/07/2021
Initial Report FDA Received Date09/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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