MAUDE Adverse Event Report: SSYNTHES USA; NAIL, FIXATION, BONE

Device Problem Sticking (1597)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient had initial underwent a tfn-advanced proximal femoral nailing system (tfna) on (b)(6) 2015.Post-operatively, the screw cut out.On (b)(6) 2015 patient returned for revision surgery to explant the helical blade, nail and distal locking screw.Patient was converted to a total hip replacement.There was no surgical delay.The surgery was completed successfully.The post-surgical outcome/status of the patient is unknown.Patient history shows osteoporosis.This report is 2 of 2 for (b)(4).

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SSYNTHES 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: 5369099
• MDR Text Key: 36023109
• Report Number: 2520274-2016-10243
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• 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
• Date Manufacturer Received: 12/29/2015
• 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