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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 PRCSN MTCH HD, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 3.0MM PRCSN MTCH HD, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Model Number 8450107530
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/02/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.
 
Event or Problem Description
It was reported that during a mis (minimally invasive spine) procedure, the bur broke.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
3.0MM PRCSN 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 Key12533367
Report Number3015967359-2021-02070
Device Sequence Number11097048
Product Code HBE
UDI-Device Identifier07613327097023
UDI-Public07613327097023
Combination Product (Y/N)N
Initial Reporter StateMN
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) 09/27/2021
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 Number8450107530
Device Catalogue Number8450107530
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/02/2021
Initial Report FDA Received Date09/27/2021
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
5407120950F, SN (B)(4); 5407120950F, SN (B)(4)
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