MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 100MM; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 456.305

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient identifier not available for reporting.Date of device migration not known.(b)(4).Lot number unknown.Date of implant reported as three (3) weeks prior to explant.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant device therapy date reported as three (3) weeks prior to explant.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.

Event Description

It was reported that a patient was implanted with a trochanteric fixation nail (tfn) and helical blade on an unknown date approximately three weeks prior to explant date for a right fractured femur.On an unknown date, the patient returned to the emergency department complaining of pain.X-rays taken at the emergency department identified a varus deformity and a possible cut-out of the nail and helical blade at the interior proximal femur.Patient was returned to the operating room on (b)(6) 2017 for revision.The revision procedure included femur reduction and repositioning a new guide wire into the femoral neck, and a new nail and helical blade were implanted to correct the varus deformity.This was confirmed with ap and lateral x-rays taken during the procedure.There was no surgical delay, and the revision surgery was completed.The patient remained stable during and following the procedure.Concomitant device reported: tfn nail (part 456.414s, lot number unknown, quantity 1) this report is for one (1) 11.0mm helical blade.This is report 1 of 1 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 100MM
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6867023
• MDR Text Key: 86258839
• Report Number: 3003506883-2017-10201
• 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: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 456.305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2017
• 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 Age: 85 YR
• Patient Weight: 57