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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG TWIST DRILL, DIAM. 1.9X58MM, FOR 6+7MM SCREW LENGHT, STRYKER SHAFT END; INSTRUMENT
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STRYKER LEIBINGER FREIBURG TWIST DRILL, DIAM. 1.9X58MM, FOR 6+7MM SCREW LENGHT, STRYKER SHAFT END; INSTRUMENT Back to Search Results
Catalog Number 92-19758
Health Effect - Clinical Code Injury (2348)
Date of Event 09/09/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device unable to be returned for evaluation.
 
Event or Problem Description
It was reported by the company representative that during a case, the surgeon was pulling the drill (with bit) out of the patient's mouth, and the bit was bent which caused the surgeon to cut the patient's mouth.The patient received stitches.
 
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Brand Name
TWIST DRILL, DIAM. 1.9X58MM, FOR 6+7MM SCREW LENGHT, STRYKER SHAFT END
Common Device Name
INSTRUMENT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
MDR Report Key9157981
Report Number0008010177-2019-00061
Device Sequence Number14436864
Product Code HBE
UDI-Device Identifier07613154629442
UDI-Public07613154629442
Combination Product (Y/N)N
Initial Reporter StateNJ
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) 10/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number92-19758
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/09/2019
Initial Report FDA Received Date10/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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