MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9 MM / TI CANN FRN / GT 400MM / LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.033.971S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 an unknown date in 2020, the patient was brought back to the operating room to correct the malrotation of the left femur.Initially, the patient was implanted with a femoral recon nail system (frns) on (b)(6) 2020.The three (3) unknown screws were removed and the nail was externally rotated along with the distal femur.The three (3) unknown screws were reinserted into the nail.All hardware came out easily and nothing was broken.There was no hardware failure and no x-rays are available.The patient outcome was unknown.This complaint involves four (4) devices.This report is for one (1) 9 mm / ti cann frn / gt 400mm / left - sterile.This is report 1 of 4 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 corrected data.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: 9 MM / TI CANN FRN / GT 400MM / LEFT - STERILE
• 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: 10214353
• Report Number: 2939274-2020-03042
• Device Sequence Number: 2095421
• Product Code: HSB
• UDI-Device Identifier: 10886982272355
• UDI-Public: (01)10886982272355
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 04.033.971S
• Device Catalogue Number: 04.033.971S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR