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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 TAA1140-F-205
Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)
Patient Problem No Code Available (3191)
Event Date 05/09/2019
Event Type  malfunction  
Event Description
According to the surgeon, the second most distal locking screw backed out and a secondary distal fixation by reinsertion of the backed out locking screw with additional pollar screws and a small plate was carried out in (b)(6) 2018. In (b)(6) 2019 total loss of fixation and failure of unition of the osteotomy was diagnosed. On nail removal a nail breakage through the proximal locking screw hole was noted. The bipolar feedline of the receiver was also broken. There is no information about an event that leads to this fracture.
 
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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 Key9887733
MDR Text Key189498484
Report Number3003236810-2020-00008
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K163368
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/02/2021
Device Model NumberTAA1140-F-205
Device Catalogue Number60001383
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/27/2020 Patient Sequence Number: 1
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