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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 52-509-05-07
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 06/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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, an additional follow-up report will be submitted.
 
Event or Problem Description
It was reported the twist drills broke during use and portion remains implanted.
 
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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 Key12111998
Report Number9610905-2021-00058
Device Sequence Number17001003
Product Code HTW
UDI-Device Identifier00888118085139
UDI-Public(01)00888118085139
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
CLS 1 EXEMPT
Exemption Number2017029
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/07/2021
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 Number52-509-05-07
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/07/2021
Initial Report FDA Received Date07/02/2021
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 Age34 YR
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