MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 95 ANGLE BLADE PLATE 70MM BLADE/10 HOLE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Catalog Number CD283.016

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

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.Product was not returned.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.(b)(4).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) 2020 the patient underwent the removal of an angle blade plate and six (6) screws because it failed to comminute the fracture further distal.The patient has been treated for a non-union proximal femur approximately 3 weeks ago with angle blade plate and was instructed to limit weight bearing to 0-25% for transfers only.The patient did not comply and was walking, internal fixation could not handle the weight load.Proximal femoral nailing system (tfna) implants were used to treat the revised non-union.The procedure outcome and patient status were unknown.The patient had suffered injuries a few years prior and was treated at another hospital.The initial trauma evaluation three (3) years ago diagnosed a proximal tibia fracture.Unknowingly, it appears at the time they completely missed the proximal femur fracture.The proximal femur fracture was not discovered until (b)(6) 2020.This report is for one (1) 95° angle blade plate 70mm blade/10 hole.This is report 1 of 7 for (b)(4).

• Brand Name: 95 ANGLE BLADE PLATE 70MM BLADE/10 HOLE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10507615
• MDR Text Key: 206126122
• Report Number: 2939274-2020-04036
• Device Sequence Number: 1
• Product Code: KTW
• 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: Physician
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CD283.016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/09/2020
• 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 Age: 66 YR