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

Model Number SEF20000

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/02/2018

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, according to user report (b)(4), approximately 1.5 cm worth of k-wire was broken off in the most proximal aspect while placing a proximal crossing k-wire.This was found to be on x-ray completely within the tibia and as such was unable to retrieve this k-wire.The case was an open reduction of lisfranc's fracture with bone putty and ilizarov frame.

• Brand Name: SALVATION
• 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: 7521673
• MDR Text Key: 108493083
• Report Number: 1043534-2018-00036
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2018,04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEF20000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2018
• Distributor Facility Aware Date: 04/19/2018
• Event Location: Hospital
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 109