MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. CORETRAK(R); APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE

Device Problem Device Inoperable (1663)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly, during removal of coretrack external fixation, the driver broke.A backup driver was used to attempt to remove the coretrack however it broke off also.A bolt cutter was used to cut off the coretrack.The surgeon believes the patient got the coretrack wet repeatedly with washing during the past 2 months.

• Brand Name: CORETRAK(R)
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer Contact: 1023 cherry road; 901451-631
• MDR Report Key: 7490312
• MDR Text Key: 107463085
• Report Number: 1043534-2018-00034
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/09/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other