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 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

The event problem and evaluation codes were only chosen according to the surgeons event report.More specific codes are available after investigation.

Event Description

The surgeon reported that there was no motor noise three weeks after the surgery.

• 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: 9887734
• MDR Text Key: 189498428
• Report Number: 3003236810-2020-00009
• 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: health professional
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: TAA1180-F-245
• Device Catalogue Number: 60001404
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 23 YR