MAUDE Adverse Event Report: SYNTHES USA 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 456.421

Device Problem Break (1069)

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

Event Type  Injury  

Manufacturer Narrative

Additional device code used hwc.(b)(4) lot number unknown.Exact date of implant is unknown.It was reported that the implant procedure was approximately two years from the date of explant procedure (b)(6) 2016.Device is not expected to be returned for manufacturer review/investigation.(b)(4).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

It was reported that on (b)(6) 2016, patient underwent revision procedure to remove hardware.Patient was implanted with trochanteric fixation nail (tfn), helical blade, and screw approximately two (2) years prior to explant.On unknown date, the patient experienced pain.An x-ray on an unspecified date revealed that the tfn had broken at the intersection of the helical blade and had a non-union.During the revision surgery, surgeon removed all hardware.All extracted devices were intact, except for the nail.The patient was revised to a proximal femur plate and screws.Surgery was completed successfully with no delay and no harm to patient.Concomitant devices reported: helical blade (part# unknown, lot # unknown, quantity unknown).Screw (part# unknown, lot # unknown, quantity unknown).This report is for one (1) trochanteric fixation nail (tfn).This is report 1 of 1 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT
• 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: 6099186
• MDR Text Key: 59751138
• Report Number: 2520274-2016-15370
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011857
• 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: 10/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 456.421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2016
• 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
• Treatment: UNKNOWN QUANTITY OF UNKNOWN HELICAL BLADE; UNKNOWN QUANTITY OF UNKNOWN SCREW
• Patient Outcome(s): Required Intervention
• Patient Weight: 54