MAUDE Adverse Event Report: SYNTHES SYNTHES; INERMEDULLARY NAIL

Model Number 04.004.446S

Device Problem Insufficient Information (3190)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/20/2014

Event Type  No Answer Provided  

Event Description

Patient had left tibia varus nonunion and left fibular malunion and nonunion.During procedure, an intramedullary nail and 2 screws in the lateral proximal tibial metaphysis was removed.

• Brand Name: SYNTHES
• Type of Device: INERMEDULLARY NAIL
• Manufacturer (Section D): SYNTHES
• MDR Report Key: 3639437
• MDR Text Key: 4179137
• Report Number: MW5034593
• Device Sequence Number: 1
• Product Code: HTY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.004.446S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 98