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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM CARBIDE ROUND EXTENDED; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM CARBIDE ROUND EXTENDED; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Model Number 5820110340C
Medical Device Problem Code Expiration Date Error (2528)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/06/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
 
Event or Problem Description
It was reported that during a cervical posterior laminoplasty laminectomy procedure, an expired bur was used, this was noted after the procedure.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
 
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Brand Name
4.0MM CARBIDE ROUND EXTENDED
Common Device Name
DRILLS, BURRS, TREPHINES & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12713835
Report Number3015967359-2021-02417
Device Sequence Number4239479
Product Code HBE
UDI-Device Identifier07613327294668
UDI-Public07613327294668
Combination Product (Y/N)N
Initial Reporter CountryNZ
PMA/510(K) Number
K143320
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse Practitioner
Type of Report Initial
Report Date (Section B) 10/28/2021
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 Expiration Date06/01/2021
Device Model Number5820110340C
Device Catalogue Number5820110340C
Device Lot Number19162017
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/06/2021
Initial Report FDA Received Date10/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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