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

Model Number 60001383-00-0

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 01/15/2021

Event Type  malfunction  

Event Description

Information provided states that the patient had a fitbone nail implanted in the femur on (b)(6) 2020.It was noticed during a post-op visit on (b)(6) 2021 that there was no lengthening of the nail.The distributor representative tested the nail for distraction on (b)(6) 2021 using a 2nd control unit.The nail failed to lengthen with the new control unit.A revision surgery will be scheduled to further patient's treatment.

• Brand Name: FITBONE
• Type of Device: INTRAMEDULLARY LENGTHENING NAIL
• Manufacturer (Section D): WITTENSTEIN INTENS GMBH; walter-wittenstein-str. 1; igersheim, germany 97999 ; GM 97999
• MDR Report Key: 11325533
• MDR Text Key: 245491218
• Report Number: 2183449-2021-00001
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04260170143938
• UDI-Public: 04260170143938
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/20/2021,02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 60001383-00-0
• Device Catalogue Number: 60001383-00-0
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2021
• Event Location: Home
• Date Report to Manufacturer: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR