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 12/21/2020

Event Type  malfunction  

Event Description

No lengthening can be noticed.

Manufacturer Narrative

The internal investigation was performed.The endpiece right was swan off.Power was supplied directly at the motor.However, the motor functioned with a much too high current input of 40 ma.After the functionality check, the decision was further testing of the nail according to the following procedure: the nail was disassembled and the motor was cut out of the housing.While repeating functionality check of the motor, the motor showed no function.Therefore the transmission was disassembled, but the root cause can´t be found.

• 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: 13936150
• MDR Text Key: 288878163
• Report Number: 3003236810-2022-00027
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• 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?: No
• 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: 15 YR