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

Model Number TAA1160-F-225

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2021

Event Type  malfunction  

Event Description

After several attempts, no information on the current status at the clinic and the receiver is not available for further examinations.As there is still no possibility to examine the product, the case is closed.An investigation of the product is absolutely necessary to analyse the root cause.

• 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: 13504506
• MDR Text Key: 288097790
• Report Number: 3003236810-2022-00025
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: TAA1160-F-225
• Device Catalogue Number: 60001468
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2021
• 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