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

Model Number TAA1180-F-245

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

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.

• Brand Name: FITBONE
• Type of Device: INTRAMEDULLARY 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 Key: 10984208
• MDR Text Key: 220725666
• Report Number: 3003236810-2020-00015
• 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

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2020
• Device Model Number: TAA1180-F-245
• Device Catalogue Number: 60001404
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• 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