MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE,FIXATION,NAIL

Device Problem Malposition of Device (2616)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: event date: unknown this report is for unknown - pfna2 blade/unknown lot number.(b)(4).Original implant date is unknown.Revision surgery unknown at this time.Device is not expected to be returned for manufacturer review/investigation.(b)(6).The 510k#: unknown.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 proximal femoral nail antirotate blade (pfna2) pulled out post-operatively by an obese patient.The patient has not yet started to do weight-bearing.No information available about patient condition, outcome and if a revision surgery was performed.This complaint involves 1 part.Concomitant reported part: 1x pfna nail (part unk, lot unknown).Ths report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the received x-ray pictures show that the blade pulled-out as per complaint description; therefore the complaint is confirmed.Product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Manufacturer Narrative

Updated product investigation was completed: the device is reportedly still implanted in the patient and was not available for investigation.The received x-ray pictures show that the blade pulled-out as per complaint description; therefore the complaint is confirmed.A possible reason for the fixation failure is an incorrect entry point which may have led to poor fracture reduction in varus and a direct load transfer to the blade.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.

• Type of Device: APPLIANCE,FIXATION,NAIL
• 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: 6457519
• MDR Text Key: 71684161
• Report Number: 2520274-2017-11190
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• 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: 06/13/2017
• 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