MAUDE Adverse Event Report: SYNTHES (USA); NAIL,FIXATION,BONE

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

Patient identifier, age or date of birth, and weight are not available for reporting.This report is for an unknown helical blade.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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 report that the patient had original surgery on (b)(6) 2017 for treatment of a femur fracture using the trochanteric fixation nail advanced (tfna) system.Patient was implanted with one (1) tfna long nail, one (1) helical blade and one (1) distal locking screw.On (b)(6) 2017, post-operatively, it was observed thru x-ray that the helical blade implant was not inserted correctly thru the tfna nail.The tfna blade was inserted into the head and neck of the patient¿s femur without going through the tfna nail.The blade was oriented posterior to the nail in the patient¿s femur.On (b)(6) 2017, patient was brought back to the operating room.Surgeon removed the previously implanted helical blade implant, and re-implanted another helical blade thru the tfna nail correctly.To complete the blade insertion the surgeon also pulled out the tfna nail posterior so the aiming arm instrument could be used to obtain the correct placement of the blade.It was reported that no fragments were generated during implant removal.Revision surgery was completed successfully with no time delay.Patient is reported in stable condition.Concomitant devices reported: distal locking screw (quantity 1), trochanteric fixation nail advanced (tfna) nail (quantity 1).This report is for one (1) unknown tfna helical blade.This is report 1 of 1 for (b)(4).

• Type of Device: NAIL,FIXATION,BONE
• 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: 6677479
• MDR Text Key: 78718931
• Report Number: 2520274-2017-11899
• 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: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• 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: 06/01/2017
• 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
• Treatment: LOCKING SCREW (PART AND LOT UNKNOWN, QTY 1); TFNA NAIL (PART AND LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention