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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL FOR 20MM, 1.5X107.5MM, STRYKER-SHAFT; INSTRUMENT
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STRYKER LEIBINGER FREIBURG DRILL FOR 20MM, 1.5X107.5MM, STRYKER-SHAFT; INSTRUMENT Back to Search Results
Model Number 60-15920
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/24/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
 
Event or Problem Description
It was reported by a company representative that the device snapped as the surgeon was pulling the drill bit out and the other became stuck in the bone as they were drilling in the mandible and snapped off of the shaft.Drill fragments were retrieved from the patient.No other information is known at this time.
 
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Brand Name
DRILL FOR 20MM, 1.5X107.5MM, STRYKER-SHAFT
Common Device Name
INSTRUMENT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
DE  D-79111
MDR Report Key10404876
Report Number0008010177-2020-00043
Device Sequence Number17061083
Product Code HBE
UDI-Device Identifier07613154183975
UDI-Public07613154183975
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K070876
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) 08/13/2020
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 Number60-15920
Device Catalogue Number60-15920
Device Lot NumberAF06/BB
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/24/2020
Initial Report FDA Received Date08/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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