MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES; PLATE,FIXATION,BONE

Device Problem Migration (4003)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Occupation: j & j employee.This report is for an unk - plates/ unknown lot.Part and lot numbers are unknown; udi number is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Without a lot number the device history records review could not be completed.Product was not returned.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 on (b)(6) 2016, a patient underwent a left radial head open reduction and internal fixation and a left lateral collateral ligament repair due to left elbow fracture dislocation and was implanted with two (2) unknown 1.5 mm screws and an unknown plate as washer.On (b)(6) 2016 the patient states that since the surgery, she has been experiencing a lot of swelling and pain.She states that she feels almost as much pain in her left wrist as she does in her left elbow.She has undergone x-rays (wrist complete left 3 views) and found out a focal soft tissue swelling at the ulnar aspect of the distal forearm.On (b)(6) 2016, the patient experienced slight pain and popping at the end of range of motion based on the physical exam.On (b)(6) 2016, the patient had a status post left radial head open reduction and internal fixation lateral collateral ligament repair with likely radial head nonunion.According to the x-ray findings of the elbow complete left min 3 views, there may be further radial migration of the radial head fracture when compared to prior as well as decreased bone purchase of screws on the oblique view.On (b)(6) 2016, patient underwent a surgery for a left radial head replacement and removal of hardware, left elbow.She sustained an elbow dislocation with radial head fracture and coronoid fracture.Her lateral ligament was repaired and placed the screws in the radial head.She went on to develop a nonunion of the radial head fragment and continued to have pain with clicking with any sort of rotation.On (b)(6) 2016, the patient started using some scare strips on her left elbow incision and has started to notice part of the incision opened and closed over and just started to get yellow pus and drainage from the upper part of the incision.There is some redness and erythema at the proximal part of the elbow incision.Still having medial pain 2 months past surgery.She has pain with deep flexion.This report is for 1 of 3 for (b)(4).

• Brand Name: UNK - PLATES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9257429
• MDR Text Key: 174182049
• Report Number: 2939274-2019-61838
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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: 10/14/2019
• 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