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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG TWIST DRILL
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KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG TWIST DRILL Back to Search Results
Model Number 25-449-16-91
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 11/03/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The failure root cause cannot be determined due to the device not being returned.If further information is obtained that might add value to the contents of the investigation report, a follow-up review will be noted herein.
 
Event or Problem Description
It was reported the twist drill broke during use and a portion remained in the patient.
 
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Brand Name
TWIST DRILL
Common Device Name
TWIST DRILL
Manufacturer (Section D)
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
kolbinger strasse 10
muehlheim/donau, 78570
GM  78570
MDR Report Key9403682
Report Number9610905-2019-00228
Device Sequence Number2167099
Product Code HTW
UDI-Device Identifier00888118040817
UDI-Public(01)00888118040817
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
CLS 1 EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/03/2019
Report Date (Section F) 11/03/2019
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 Model Number25-449-16-91
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/03/2019
Event Location Hospital
Date Report to Manufacturer11/03/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/03/2019
Initial Report FDA Received Date12/03/2019
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 Other;
Patient Age72 YR
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