MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PR 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT; IMPLANT,FIXATION DEVICE CONDYLAR PLATE

Model Number	02.124.413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc ; device is not expected to be returned for manufacturer review/investigation.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.Device was used for treatment, not diagnosis.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.
Event or Problem Description
It was reported that a patient had a 13 hole 4.5 (variable angle locking plate)va-lcp condylar plate 02.124.413 lot#l020868 in (b)(6) 2017.Patient reported to operating room with complaint of pain.X-ray showed the plate had broken between the 3rd and 4th shaft hole distally due to a delayed non union.Plate was removed on (b)(6) 2017 and replaced with a rafn (retrograde anterograde fixaion nail) nail.The surgery was completed successfully.No complications were reported.This complaint is for one device this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: part no.: 02.124.413.Lot no.: l020868, manufacturing location: (b)(4).Release to warehouse date: 20.Jun.2016.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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT
• Common Device Name: IMPLANT,FIXATION DEVICE CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PR; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7207006
• Report Number: 2939274-2018-50304
• Device Sequence Number: 16324418
• Product Code: JDP
• UDI-Device Identifier: 10886982042873
• UDI-Public: (01)10886982042873(10)L020868
• Combination Product (Y/N): N
• Initial Reporter State: WA
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 12/22/2017

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: 02.124.413
• Device Catalogue Number: 02.124.413
• Device Lot Number: L020868
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 03/01/2018
• 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