MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 10/08/2014

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the products were used for femur trochanter comminuted fracture on (b)(6) 2014.The patient had a pain the next day.According to x-ray, the patient¿s bone cracked at the distal part.The patient continued to experience pain.On (b)(6) 2014, it was found out by x-ray that the fixation at the distal part was broken.The patient walked under weight-bearing control after the surgery.This report is for an unknown plate.(b)(4).

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part numbers 481.140s 135 deg ti lc-dhs® plate-standard barrel 4 holes/78mm and 481.871s locking trochanter stabilizing plate for dhs, adjustable, were reported, but it is unknown which one was involved in the complaint.Part 481.140s: k953607; part 481.871s: device is not distributed in the united states, but is similar to device marketed in the usa.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.

• Type of Device: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
• 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: 4247747
• MDR Text Key: 5109120
• Report Number: 2520274-2014-14692
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2014
• 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