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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.5MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 1.5MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Model Number 5820103015
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/18/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.Device discarded.
 
Event or Problem Description
It was reported that during a cranioplasty surgical procedure in the patient¿s skull, the drill bit broke approximately 10mm from the tip and the fragment was easily removed.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
 
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Brand Name
1.5MM WIRE PASS DRILL BIT
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 Key11923492
Report Number3015967359-2021-01032
Device Sequence Number3215125
Product Code HBE
UDI-Device Identifier04546540362421
UDI-Public04546540362421
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K143320
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/02/2021
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 Date10/01/2023
Device Model Number5820103015
Device Catalogue Number5820103015
Device Lot Number20298017
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/18/2021
Initial Report FDA Received Date06/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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