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

Model Number TAA1180-T-245

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

We have been informed, that a nail is broken.No further information available.

Manufacturer Narrative

We have been informed, that a nail is broken.No further information available.

• 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 kohlhepp ; walter-wittenstein-strasse 1; igersheim 97999 ; GM 97999
• MDR Report Key: 13617737
• MDR Text Key: 289068172
• Report Number: 3003236810-2021-00026
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TAA1180-T-245
• Device Catalogue Number: 60001348
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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