MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PROXIMAL TIBIA PLATE; PLATE,FIXATION,BONE

Model Number 02.124.209

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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.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) 2021, during a tibia plateau fracture, it was noticed that the bend of the low bend 3.5 proximal tibia plate because the screws were aiming into the joint.The surgeon removed the plate and bent the plate and proceeded with the surgery successfully.There was an unknown surgical delay.Patient outcome is unknown.This complaint involves one (1) device.This report is for (1) 3.5mm lcp proximal tibia plate.This report is 1 of 1 for (b)(4).

• Brand Name: 3.5MM LCP PROXIMAL TIBIA PLATE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12310337
• MDR Text Key: 266204669
• Report Number: 2939274-2021-04612
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982042552
• UDI-Public: (01)10886982042552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011978
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.209
• Device Catalogue Number: 02.124.209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 102