MAUDE Adverse Event Report: SYNTHES USA 5.0MM CANNULATED VA LOCKING SCREW/75MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.675

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

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Additional codes: hrs, hwc.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The manufacture date is unknown.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 a patient, who was implanted with one (1) distal femoral locking plate and an unknown number of locking screws on (b)(6) 2015, has experienced painful hardware.The patient reported that the hardware bothers her all the time and she reportedly suspected that she was having an allergic reaction to the previously implanted distal locking plate and screws.The plate and locking twelve (12) screws were explanted on (b)(6) 2017.The patient was reportedly fully healed.During the procedure, the surgeon reported that there were no signs of an allergic reaction.Blood work showed no signs of an allergic reaction or of an infection.The treating physician will, reportedly test the patient for allergies.It explanted devices were easily removed intact, without any additional medical intervention being required and without any patient harm.The explanted devices are not available for investigation.No additional information is available.This is report 7 of 13 for (b)(4).

• Brand Name: 5.0MM CANNULATED VA LOCKING SCREW/75MM
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• 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: 6382001
• MDR Text Key: 69202831
• Report Number: 2520274-2017-10746
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• 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
• Patient Weight: 108