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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Non-union Bone Fracture (2369)

Event Date 06/16/2012

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.This report is for an unknown pfn nail/unknown quantity/unknown lot.(b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following journal article, ¿intrapelvic migration of hip lag screw of proximal femoral nail-sequele to a paradoxical reverse z effect and their critical analysis¿ (june 16, 2012).Lal, h., mittal, d., and sharma, d.Journal of clinical orthopaedics and trauma 3 (2012) 48-53.A (b)(6) male treated with dynamic condylar screw (dcs, synthes) for unstable inter trochanteric fracture femur.At 6 weeks he was sent to physiotherapy department for mobilization of his knee.Due to some untoward incident during mobilization session a click sound was felt by the patient in the hip region.Subsequent radiography showed that cut out of the distal femoral shaft, and the fracture collapsed into varus.The dynamic condylar screw was removed and fracture was fixed with proximal femoral nail (pfn, synthes).A nine week radiograph showed that the implant and bone were in anatomical position, but at 12 weeks, a radiograph showed implant failure.The proximal most of the proximal group of screw had broken and the distal one had migrated into the joint.The fracture had collapsed into varus; hence it was decided to remove the proximal interlocking screws.At the last follow-up of 2 years, the patient is able to stand and walk unaided and painlessly.This is report 1 of 1 for (b)(4).This report is for unknown pfn nail, and refers to the non-union and the device interaction with the broken screw.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4330475
• MDR Text Key: 19050366
• Report Number: 2520274-2014-15315
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR