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

Model Number TAA1180-T-245

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

Revision of receiver ( (b)(6) 2020).According to previous understanding revision of intramedullary lengthening nail and receiver ( (b)(6) 2020).

Event Description

The event became known to the manufacturer on 2020-02-14.The event information form with the information needed to assess whether an incident has occurred was received on (b)(6) 2020.According to the surgeon's information, the implant sounded different right from the beginning.The sound can be described as "starching".In addition, it became increasingly difficult to achieve a lengthening.The distraction could not be continued with 10 mm extension.At the beginning it was suspected that there was a problem with the receiver.This suspicion could be discarded after revision surgery of the receiver.Up to now, the nail was not revised, since extension was possible under relief.At a total length of 28 mm, the distraction stopped again.

Event Description

According to the surgeon's information, the implant sounded different right from the beginning.The sound can be described as "scratching".In addition, it became increasingly difficult to achieve a lengthening.The distraction could not be continued with 10 mm extension.

Manufacturer Narrative

The reason for the loosening of the locking ring of the gear shaft could not be found.There were no indications for the failure (loose locking ring) during assembly and the mandatory functionality tests prior to shipment.The failure likely occurred by mishandling (e.G.During shipment or implantation), but cannot be retraced.Therefore in this particular case, there is no preventive action or measure possible by the manufacturer.

• Brand Name: FITBONE
• Type of Device: INTRAMEDULLARY LENGTHENING NAIL
• Manufacturer (Section D): WITTENSTEIN INTENS GMBH; walter-wittenstein-str. 1; igersheim, 97999 ; GM 97999
• MDR Report Key: 9928524
• MDR Text Key: 189497016
• Report Number: 3003236810-2020-00012
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K163368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: TAA1180-T-245
• Device Catalogue Number: 60001404
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention