MAUDE Adverse Event Report: WRIGHT MEDICAL WRIGHT MEDICAL INBONE TOTAL ANKLE INSTRUMENT SET; IMPACTOR OR TRIAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/08/2017

Event Type  malfunction  

Event Description

There was a piece of what looked like blue plastic in the posterior portion of the right ankle during irrigation and debridement and removal of right total ankle on (b)(6) 2017.The original total ankle was performed on (b)(6) 2017, it was a piece from either the impactor or the trial.Physician stated the piece was not in the area of the ankle infection.

• Brand Name: WRIGHT MEDICAL INBONE TOTAL ANKLE INSTRUMENT SET
• Type of Device: IMPACTOR OR TRIAL
• Manufacturer (Section D): WRIGHT MEDICAL
• MDR Report Key: 6838751
• MDR Text Key: 84934257
• Report Number: MW5071906
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR