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

Device Problem Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Date of event is unknown.This report is for one (1) unknown helical blade.(other): without a valid part and lot number, the udi is not available.(therapy date): original implant date is reported as (b)(6), exact date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation, as part was discarded by the facility.(510k#): unknown, as specific part and lot numbers for helical blade is not provided.(b)(4).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 trochanteric fixation nail advanced (tfna) revision surgery of the right proximal femur was performed on (b)(6) 2016.The original implant was done in (b)(6) 2016 (exact date is unknown).Postoperative x-rays taken on an unknown date revealed that the helical blade has backed out 100% from the nail and that the top of the nail is broken.A proximal femur plate and three corresponding screws, 4.5 cortex screws and 5.0 locking screws, are slated to be implanted in the patient.The surgeon removed the helical blade and disposed of the device at the hospital.Hardware removal was done due to pain.No other devices were removed from the patient.Concomitant device reported: 5.0mm locking screw (part #-unknown, lot #-unknown.Quantity 1) this report is for one (1) unknown helical blade.This is report 1 of 2 for com-(b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6190335
• MDR Text Key: 62857061
• Report Number: 2520274-2016-15720
• Device Sequence Number: 1
• Product Code: HSB
• 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: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• 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: 11/28/2016
• 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: ONE (1) 5.0MM LOCKING SCREW
• Patient Outcome(s): Required Intervention