MAUDE Adverse Event Report: SYNTHES USA 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/20MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.220

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

Patient Problems Unspecified Infection (1930); Swelling (2091); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Additional product codes: hrs and hwc.(b)(4).Device was either implanted on (b)(6) 2012 or (b)(6) 2014 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.

Event Description

It was reported that due to infection, non-union, and red swollen of left thigh that was draining through small open wound around femur, patient was revised on (b)(6) 2015 to removed hardware from (b)(6) 2012 and (b)(6) 2014.All hardware was removed intact.Patient was treated with possible infection and an antibiotic nail was made by the surgeon and implanted in the medullary canal.Procedure was successfully completed and no surgical delays were reported.Patient will return to operating room at later date, once infection has cleared for revision fixation.Patient/status outcome was reported as fine.This is report 11 of 15 for (b)(4).

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/20MM
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• 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: 5364217
• MDR Text Key: 35811117
• Report Number: 2520274-2016-10200
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• 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: 12/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/24/2015
• 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