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

Model Number TAA1180-F245

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2020

Event Type  malfunction  

Event Description

A drive failure has been detected.This is expressed by the fact that no more running noise can be perceived.This results in an early discontinuation of the treatment.According to the surgeon, no cause for this can be determined so far.

Manufacturer Narrative

Internal investigation showed no function of the motor.The motor was disassembled and showed an endless high connection resistance indicating a defect in the motor.An external examination by ct was performed and showed no damage to the wires.It seems to be a defect inside the motor, which cannot be further analyzed.

• Brand Name: FITBONE
• Type of Device: INTRAMEDULLARY LENGTHENING NAIL
• Manufacturer (Section D): WITTENSTEIN INTENS GMBH; walter-wittenstein-strasse 1; igersheim, 97999 ; GM 97999
• Manufacturer Contact: nadine kohlhepp ; walter-wittenstein-strasse 1; igersheim 97999 ; GM 97999
• MDR Report Key: 13936232
• MDR Text Key: 289210386
• Report Number: 3003236810-2022-00028
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K163368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/10/2020

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
• Device Operator: Health Professional
• Device Model Number: TAA1180-F245
• Device Catalogue Number: 60001404
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR