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

Model Number TAA1160-T-225

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2022

Event Type  Injury  

Event Description

According to the event information form the nail showed no movement during intraoperative test.

Event Description

According to the event information form the nail showed no movement during intraoperative test.

• 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 richter (born: langguth) ; walter-wittenstein-strasse 1; igersheim, 97999 ; GM 97999
• MDR Report Key: 14099288
• MDR Text Key: 289174214
• Report Number: 3003236810-2022-00031
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

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: Health Professional
• Device Model Number: TAA1160-T-225
• Device Catalogue Number: 60001445-00-0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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