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

Model Number RECEIVER

Device Problem Use of Device Problem (1670)

Patient Problem Missing Value Reason (3192)

Event Date 10/23/2018

Event Type  malfunction  

Event Description

Control set is not working.After replacement also new control set does not work.Therefore it is assumed that the implanted receiver may cause a malfunction.No more detailed information.

• 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: 9887686
• MDR Text Key: 189497099
• Report Number: 3003236810-2020-00005
• 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: Replace
• 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: Lay User/Patient
• Device Expiration Date: 09/18/2021
• Device Model Number: RECEIVER
• Device Catalogue Number: 60001615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2018
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2018
• 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: 34 YR