MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM; PLATE, FIXATION, BONE

Model Number	241.361
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part has not been returned for manufacturer review/investigation.Complainant part has yet to be 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 or Problem Description
It was reported that a right ankle hardware removal was performed on (b)(6) 2018 due to patient complaints of pain.During the procedure a tibial plate and corresponding locking screws were removed.The exact amount of screws removed is unknown.The original procedure was performed on (b)(6) 2017.There was no delay or fragments generated in the patient.Everything was reported as easily removed.The patient outcome was reported as good.This complaint involves two (2) devices.This is report 1 of 2 for (b)(4).This report is for a plate.

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 6 HOLES/69MM
• 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: 7339514
• Report Number: 2939274-2018-51058
• Device Sequence Number: 16631192
• Product Code: HRS
• UDI-Device Identifier: 10886982166876
• UDI-Public: (01)10886982166876(10)H226274
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 02/13/2018

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: 241.361
• Device Catalogue Number: 241.361
• Device Lot Number: H226274
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/14/2018
• 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: 68 YR
• Patient Weight: 65