MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP® ANTEROLATERAL DISTAL TIBIA PL 15 HOLES/LEFT; APPLIANCE,FIXATION,NAIL

Model Number	241.451
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date patient pain began is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Dhr review was completed.Part no.: 241.451, lot no.: 7806237, manufacturing location: (b)(4), release to warehouse date: 07.Mar.2012.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient was implanted with a 3.5 mm locking compression plate (lcp) ® anterolateral distal tibia plate on (b)(6) 2015.On (b)(6) 2018, the patient underwent a removal surgery of the 3.5 mm lcp® anterolateral distal tibia plate due to pain.There was no surgical delay and patient outcome reported.Hardware was removed intact.This report is for one (1) 3.5 mm lcp anterolateral distal tibia plate.This is report 1 of 2 for (b)(4).

• Brand Name: 3.5MM LCP® ANTEROLATERAL DISTAL TIBIA PL 15 HOLES/LEFT
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7378701
• Report Number: 2939274-2018-51278
• Device Sequence Number: 1482715
• Product Code: KTT
• UDI-Device Identifier: 10886982167217
• UDI-Public: (01)10886982167217(10)7806237
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2018

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: 241.451
• Device Catalogue Number: 241.451
• Device Lot Number: 7806237
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/28/2018
• 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 Weight: 92