MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Impaired Healing (2378)

Event Type  Injury  

Event Description

It was reported that there was a revision surgery due to two unknown broken internal devices that are potentially synthes devices.The patient was originally treated for a compound leg fracture in the fibula and tibia in the leg above the ankle in (b)(6) of 2012.The patient reported that the injury originally occurred on (b)(6) 2012.The surgeon waited for swelling to subside and then decided to implant three devices in his leg from the heel to the knee.On an unknown date, the patient reported feeling the devices moving around and it was confirmed via x-ray that two of the three devices were broken.The item and lot numbers of the devices are unknown.The device implanted on the front bone of the leg was explanted on (b)(6) 2014.The wound became exposed and would not heal possibly because there was not much flesh on the bone.This resulted in hyperbaric treatments.The surgeon also diagnosed a (b)(6) infection for which the patient was given unknown infusion treatments.The remaining two devices were planned to be explanted on (b)(6) 2014.Then the surgeon will perform a fusion of the patient¿s foot to his leg.It is unknown if those event have occurred yet or not.This report is for three unknown trauma devices.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: event date: unknown.This report is for 3 unknown trauma devices/unknown lots.Implant date: unknown date (b)(6) 2012.One device was explanted (b)(6) 2014; two device may have been explanted (b)(6) 2014.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3813751
• MDR Text Key: 21877915
• Report Number: 2520274-2014-11480
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/23/2014

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
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 95