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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-T-245
Device Problems Mechanical Problem (1384); Insufficient Information (3190)
Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 02/14/2020
Event Type  malfunction  
Manufacturer Narrative
Revision of receiver ( (b)(6) 2020). According to previous understanding revision of intramedullary lengthening nail and receiver ( (b)(6) 2020).
 
Event Description
The event became known to the manufacturer on 2020-02-14. The event information form with the information needed to assess whether an incident has occurred was received on (b)(6) 2020. According to the surgeon's information, the implant sounded different right from the beginning. The sound can be described as "starching". In addition, it became increasingly difficult to achieve a lengthening. The distraction could not be continued with 10 mm extension. At the beginning it was suspected that there was a problem with the receiver. This suspicion could be discarded after revision surgery of the receiver. Up to now, the nail was not revised, since extension was possible under relief. At a total length of 28 mm, the distraction stopped again.
 
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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 Key9928524
MDR Text Key189497016
Report Number3003236810-2020-00012
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K163368
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTAA1180-T-245
Device Catalogue Number60001404
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2019
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: 04/06/2020 Patient Sequence Number: 1
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