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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WITTENSTEIN INTENS GMBH FITBONE INTRAMEDULLARY LENGTHENING NAIL

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WITTENSTEIN INTENS GMBH FITBONE INTRAMEDULLARY LENGTHENING NAIL Back to Search Results
Model Number TAA1180-F-245
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/10/2020
Event Type  Injury  
Event Description
It was noticed that the intramedullary lengthening nail did not distract the desired distance. In conversation with the patient it became clear that the patient only lengthened 3 x 3mm instead of 3 x 9mm. Patient treatment is delayed as a consequence of handling by patient. Repeated information of the patient by the doctor.
 
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Brand NameFITBONE
Type of DeviceINTRAMEDULLARY LENGTHENING NAIL
Manufacturer (Section D)
WITTENSTEIN INTENS GMBH
walter-wittenstein-str. 1
igersheim, 97999
GM 97999
Manufacturer Contact
eva lunz
walter-wittenstein-str. 1
igersheim, baden-wuerttemberg 97999
GM   97999
MDR Report Key10032386
MDR Text Key194487706
Report Number3003236810-2020-00013
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K163368
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTAA1180-F-245
Device Catalogue Number60001404
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/07/2020 Patient Sequence Number: 1
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