MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC Ø8.2MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/380MM/RT-STER; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.031.938S
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.The investigation could not be completed; no conclusion could be drawn, as no product was received.The device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.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.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 had revision surgery on (b)(6) 2018 due to nonunion of the right femoral shaft to remove the 8.2 mm ti adolescent lateral entry nail and two screws and replace with the 10 mm ti adolescent lateral entry nail.The 8.2 mm ti adolescent lateral entry nail along with two (2) unknown screws were originally implanted on (b)(6) 2017.The nonunion was discovered during a patient follow-up visit from original surgery and was discovered from a visual inspection of xray.The xray images is not available.The surgery was successfully completed with no delay.The patient outcome was as planned.This complaint involves two (2) device.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Investigation summary: product was not returned and no lot number was provided.Based on the information available, 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.
Additional Manufacturer Narrative
Date received by manufacturer: 3/28/2018, omitted on previous follow-up.Device used for treatment, not diagnosis.

• Brand Name: Ø8.2MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/380MM/RT-STER
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7378227
• Report Number: 2939274-2018-51265
• Device Sequence Number: 11037169
• Product Code: HSB
• UDI-Device Identifier: 10886982094360
• UDI-Public: (01)10886982094360(17)UNK(10)LOTUNK
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K070843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• 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: 04.031.938S
• Device Catalogue Number: 04.031.938S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 02/28/2018; 04/02/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 03/29/2018; 04/02/2018
• 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: 17 YR