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

Model Number TAA1180-F-245

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/10/2020

Event Type  Injury  

Event Description

It was noticed that the intramedullary lengthening nail did not distract the desired distance.In conversation with the patient it became clear that the patient only lengthened 3 x 3mm instead of 3 x 9mm.Patient treatment is delayed as a consequence of handling by patient.Repeated information of the patient by the doctor.

• 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: 10032386
• MDR Text Key: 194487706
• Report Number: 3003236810-2020-00013
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K163368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/13/2022
• Device Model Number: TAA1180-F-245
• Device Catalogue Number: 60001404
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2019
• 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): Other
• Patient Age: 14 YR