MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP PROXIMAL TIBIA PLATE 6 HOLES/118MM-LEFT; PLATE, FIXATION, BONE

Model Number	240.039
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient weight not available for reporting unknown when condition began.Device is not expected to return for investigation.(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that patient underwent original surgery for treatment of a proximal tibial fracture on (b)(6) 2016.Post-operatively, patient complained that when the weather changes,her feet would feel very cold about the implant site.On (b)(6) 2018, patient underwent hardware removal surgery and the following devices fourteen (14) were removed - one (1) proximal tibia plate, one (1) locking compression tubular plate, one (1) 8 holes locking compression plate, two (2) 4.5 mm cortex screws, four (4) 5.0 mm locking screws and five (5) 3.5 mm cortex screws.There was no reported malfunctions associated with any of the devices.All of the devices were removed easily and the patient is reported to be in stable condition.The hardware removal surgery was completed without any reported delay.This is report 1 of 6 for (b)(4).

• Brand Name: 4.5MM LCP PROXIMAL TIBIA PLATE 6 HOLES/118MM-LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7313806
• Report Number: 2939274-2018-50870
• Device Sequence Number: 13910020
• Product Code: HRS
• UDI-Device Identifier: 10886982164490
• UDI-Public: (01)10886982164490(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2018

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
• Operator of Device: Health Professional
• Device Model Number: 240.039
• Device Catalogue Number: 240.039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR