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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO T2 FEMUR Ø4,2X230 MM; SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS
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STRYKER TRAUMA KIEL DRILL, AO T2 FEMUR Ø4,2X230 MM; SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS Back to Search Results
Catalog Number 18064290
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 05/21/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device evaluated by mfr: customer reported remaining part was lost.
 
Event or Problem Description
During the jalane interlocking surgery of medullary reduction, when the partial perforation is made distal block.The 4.2 mm broca is broken and the smallest part remains inside the patient, which can not be removed.The remaining fragment is delivered to technovigilance of the hospital.Broken drill fragment remains inside the patient as there was no way to remove during the surgery.
 
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Brand Name
DRILL, AO T2 FEMUR Ø4,2X230 MM
Common Device Name
SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key8838009
Report Number0009610622-2019-00576
Device Sequence Number371736
Product Code HWE
UDI-Device Identifier04546540196880
UDI-Public04546540196880
Combination Product (Y/N)N
Initial Reporter CountryCO
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/29/2019
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 Catalogue Number18064290
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/08/2019
Initial Report FDA Received Date07/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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