MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.013.456S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: manufacturing location: (b)(4), manufacturing date: 01/08/2015, expiration date: 11/30/2023, part number: 04.013.456s, 10mm ti cann retro/antegrade femoral nail-ex/380mm ¿ sterile lot number: 7872047 (sterile), lot quantity: (b)(4).This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component(s) reviewed: part number: 21012, tialnbri13.00, lot number: 7788414, lot quantity: (b)(4).This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.(b)(4).Product was not returned.Based on the information available, it has been determined that no corrective and 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 on (b)(6) 2019, the patient underwent revision surgery due to the extraction of a sivash range of motion (srom) stem.During the procedure, the surgeon identified a spiral femoral bone fracture was sustained.The fracture occurred due to impacting a femoral retrograde rod into the distal femur.Pericapsular metallosis, as well as difficulty with disengaging the srom stem from the sleeve, was encountered.Treatment for this includes cerclage wires, lateral buttress plate, and three (3) bicortical screws.The initial implantation date was done last (b)(6) 2016.Surgical delay of multiple hours due to difficult prosthesis removal is indicated.Quite a bit of bone loss from the removal process.Patient status is unknown.This report is for one (1) 10mm ti cannulated retro/antegrade femoral nail.This is report 1 of 1 for complaint (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.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
Concomitant devices: impaction instrument (part: unknown, lot: unknown, quantity: 1).

• Brand Name: 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-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: 8587404
• Report Number: 2939274-2019-57876
• Device Sequence Number: 1638793
• Product Code: HSB
• UDI-Device Identifier: 10886982087881
• UDI-Public: (01)10886982087881
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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 Expiration Date: 11/30/2023
• Device Model Number: 04.013.456S
• Device Catalogue Number: 04.013.456S
• Device Lot Number: 7872047
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/04/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - IMPACTION INSTRUMENTS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR