MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 90 DEG CHILD OSTEOTOMY PLATE 45MM/8MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Model Number	235.290
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date is unknown date in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: the implant(s) was not returned and instead the investigation will be done based on the supplied image(s) from the attachments, an x-ray of the construct, from the attachment(s) located in notes & attachments section of the product complaint.The image(s) was reviewed and no malfunction, damage, or defect was observed on the x-ray.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history: part number: 235.290.Lot number: 2639254.Manufacturing site: (b)(4).Release to warehouse date: 13.Sep.2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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) 2020, a revision surgery occurred due to a new femur fracture.The patient underwent removal of plate and screws and was revised to a 4.5mm locking compression curved plate and unknown screws.It is not known when the original implantation of the 90 degree child osteotomy plate and three (3) unknown 4.5mm cortex screws occurred.Procedure was successfully completed.This is report 1 of 4 for (b)(4).

• Brand Name: 90 DEG CHILD OSTEOTOMY PLATE 45MM/8MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10656898
• Report Number: 2939274-2020-04600
• Device Sequence Number: 2792907
• Product Code: KTW
• UDI-Device Identifier: 10886982159953
• UDI-Public: (01)10886982159953
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K914546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2020

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: 235.290
• Device Catalogue Number: 235.290
• Device Lot Number: 2639254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2020
• Initial Report FDA Received Date: 10/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR