MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® CURVED CONDYLAR PLATE 14 HOLES/314MM-RIGHT; APPLIANCE, FIXATION, NAIL

Model Number	02.001.324
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2018, the patient underwent a hardware removal of one (1) locking compression plate condylar plate, two (2) 4.5mm unknown cortex screw, five (5) 5.0mm unknown cannulated locking screws, one (1) 7.3mm unknown cannulated locking screw and four (4) unknown independent lag screws due to non-union of distal femur.There was no product malfunction reported.Reamer/irrigator/aspirator was used to harvest bone graft and implantation of zimmer retrograde nail was done.It is unknown if there was surgical delay.The procedure was completed successfully, and patient outcome was as planned.This report is for one (1) 4.5mm lcp curved condylar plate 14 holes.This is report 1 of 5 for complaint (b)(4).

• Brand Name: 4.5MM LCP® CURVED CONDYLAR PLATE 14 HOLES/314MM-RIGHT
• 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: 8066125
• Report Number: 2939274-2018-54955
• Device Sequence Number: 14062076
• Product Code: KTT
• UDI-Device Identifier: 10886982027696
• UDI-Public: (01)10886982027696
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K041911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

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: 02.001.324
• Device Catalogue Number: 02.001.324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention