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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 3.0MM DMND MTCH HD, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 3.0MM DMND MTCH HD, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Model Number 8450107030D
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/19/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.
 
Event or Problem Description
It was reported that during a posterior lumbar fusion procedure, the bur broke.It was also reported that there was a ten minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
 
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Brand Name
3.0MM DMND MTCH HD, 13CM
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 Key12052610
Report Number3015967359-2021-01232
Device Sequence Number11674545
Product Code HBE
UDI-Device Identifier07613327097061
UDI-Public07613327097061
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K143540
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) 06/23/2021
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 Number8450107030D
Device Catalogue Number8450107030D
Device Lot NumberUNKNOWN
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/27/2021
Initial Report FDA Received Date06/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
5407120950C SN (B)(4).
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