MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/14 HOLES/LEFT; PLATE,FIXATION,BONE

Model Number	02.118.013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of event is unknown.Additional device code: hwc.Date of implant is an unknown date in (b)(6) 2017.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review is pending completion.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 patient was implanted with a synthes 2.7 / 3.5 mm variable angle locking compression plate (va-lcp) medial distal plate, seven (7) 3.5 mm cortex screws, and four (4) 2.7 mm va locking screws on an unknown date in (b)(6) 2017.On an unknown date, it was identified that the plate had broken and that there was a non-union of the fracture, and the surgeon indicated that he permitted the patient to weight bear prematurely.On (b)(6) 2017, the patient was returned to the operating room where the implants were removed and the patient was revised to an unknown tibial nail.The procedure was completed successfully without delay and the patient was reported to be in stable condition.Concomitant devices reported: 3.5 mm cortex screws (part# unknown, lot# unknown, quantity 7), 2.7 mm va locking screws (part# unknown, lot# unknown, quantity 4).This report is for one (1) 2.7/3.5 mm va-lcp medial distal tibia plate/14 holes/left.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Part no.: 02.118.013 lot no.: 8874937 manufacturing location: (b)(4).Release to warehouse date: 24.Mar.2014 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.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.

• Brand Name: 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/14 HOLES/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: 7205446
• Report Number: 2939274-2018-50307
• Device Sequence Number: 1174922
• Product Code: HRS
• UDI-Device Identifier: 10886982037800
• UDI-Public: (01)10886982037800(10)8874937
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.118.013
• Device Catalogue Number: 02.118.013
• Device Lot Number: 8874937
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/16/2018
• 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: 51 YR
• Patient Weight: 119