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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL F. 20MM SCREWS 1.6X58MM, STRYKER SHAFT; INSTRUMENT
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STRYKER LEIBINGER FREIBURG DRILL F. 20MM SCREWS 1.6X58MM, STRYKER SHAFT; INSTRUMENT Back to Search Results
Catalog Number 60-16526
Health Effect - Clinical Code Injury (2348)
Date of Event 02/11/2019
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 discarded at facility.
 
Event or Problem Description
It was reported that the surgeon was using a twist drill off-label with a gas-powered micro air drill.After he inserted the twist drill, he pulled the trigger to test, and the twist drill fractured off at a 90-degree angle, forcing the broken fragment to become lodged into the doctor's knuckle.The twist drill had to be removed by another surgeon.
 
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Brand Name
DRILL F. 20MM SCREWS 1.6X58MM, STRYKER SHAFT
Common Device Name
INSTRUMENT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
MDR Report Key8407786
Report Number0008010177-2019-00006
Device Sequence Number13966486
Product Code HBE
UDI-Device Identifier04546540731876
UDI-Public04546540731876
Combination Product (Y/N)N
Initial Reporter StateMA
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) 03/11/2019
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? No
Operator of Device Health Professional
Device Catalogue Number60-16526
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/11/2019
Initial Report FDA Received Date03/11/2019
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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