MAUDE Adverse Event Report: SYNTHES USA; ROD,FIXATION,INTRAMEDULLARY

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional device product code use: hwc.Device has not been explanted.The patient expects to have a hip replacement done in (b)(6) of 2017.Device is not expected to be returned for manufacturer review/investigation.(b)(4).This report is for two (2) unknown screws.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.Device 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.

Event Description

A patient reported that he had an 11mm 130 degree synthes tfn device implanted in his left leg at the hospital on (b)(6) 2014.The operation was considered a success with no complications.The patient has complained of pain since the surgery was completed.The patient has since seen the doctor a total of about 4 times since the operation.The last time was in (b)(6) 2016.The doctor said that the hardware was loose and that the patient will need a hip replacement.A cardiac catheterization for artery blockages was performed this past (b)(6) of 2016, to implant 2 stents inside the patient.Initial doctor said that he could not perform a hip replacement surgery until (b)(6) of 2017.Another doctor confirmed initial doctor¿s opinion of needing a hip replacement.The patient has since lost 40 pounds in the first 30 days after surgery, and has become nauseated since then on a frequent basis.His blood count is elevated.And blood pressure drops every time he stands up.He also gets dizzy when having to stand.The hardware is loose and has to come out, according to the surgeon.The patient wants to get tested on a possibility of an allergy to the composition of the implant.The patient would like to know the composition of the alloy in the implant.There were no complications of the surgery, and the x-rays revealed that everything looked good at the time the surgery was completed.3 months after the surgery was completed, the doctor believed that the patient was alright and released him from the doctor¿s care.The patient expects to have a hip replacement done in (b)(6) of 2017.A letter will be sent to the patient of the alloy composition of the implant, at his request.The patient said that the tfn is made up of a helical blade, a nail and 2 unknown screws.He does not have any part or lot numbers of these devices.This report is for two (2) unknown screws.This is report 3 of 3 for (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6114395
• MDR Text Key: 60412419
• Report Number: 2520274-2016-15445
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2016
• 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