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

Device Problem Break (1069)

Patient Problems Fall (1848); Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Previously reported information was not duplicated if not necessary.Patient information is not available for reporting.This report is for one, unknown femoral plate.Other number¿udi: unknown part number, udi is unavailable.The subject device is not expected to be returned to the synthes manufacturer for evaluation.Without a lot number the device history records review could not be completed.The date of manufacture and synthes manufacturing location are unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Maude report # 5066876 was received by synthes customer quality on january 18, 2017 from the food and drug administration.It was reported ¿the patient had right femur fracture on an unknown date in 2016, which was repaired using plates and screws.On an unknown date in 2016 the patient had a twisting injury and fell.Patient was found to have a broken right distal femoral plate through one of the screw holes at the level of the previous fracture.It was felt to be a failure fracture of the distal plate.Dates of use 9 months.¿ only information not previous reported to the fda or corrected information will be submitted in this report.Concomitant devices - unknown screws (part number unknown, lot number unknown, quantity unknown.) this report is for one, unknown femoral plate.This report is 1 of 1 for (b)(4).

• Type of Device: PLATE, 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: 6326923
• MDR Text Key: 67280475
• Report Number: 2520274-2017-10464
• Device Sequence Number: 1
• Product Code: HRS
• 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,other
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• 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?: Yes
• Date Manufacturer Received: 01/18/2017
• 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: UNKNOWN SCREWS, QUANTITY UNKNOWN
• Patient Outcome(s): Required Intervention