MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC.; PIN, FIXATION, THREADED

Model Number UNKNOWN

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/15/2016

Event Type  Injury  

Event Description

During total knee replacement, the pin was threaded into right tibia.The pin fractured and a piece of it remains in the right tibia.In the best interest of the patient, the fractured piece will remain in the tibia.Patient disclosure was completed.

• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 1023 cherry road; memphis TN 38117
• MDR Report Key: 6180723
• MDR Text Key: 62550663
• Report Number: 6180723
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2016
• Event Location: Other
• Date Report to Manufacturer: 11/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR