MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.057S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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.(b)(4).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, the patient was treated for a femoral neck ¿stress fracture¿ with 6.5 cannulated screws.Two days later, patient experienced a fall and suffered a proximal femur fracture.The cannulated screws were removed and a titanium cannulated trochanteric fixation nail advanced (tfna) was implanted with a helical blade.Patient resumed normal activity for 117 days at which point they experienced another proximal femur fracture after the tfna nail broke at the nail/blade junction.It is unknown if the patient underwent a revision/removal procedure.Concomitant devices: tfna helical blade (part: 04.038.380s, lot: unknown, quantity: 1), locking screw (part: unknown, lot: unknown, quantity: unknown).This report is for a 10mm/130 degree titanium (ti) cannulated tfna nail.This is report 1 of 1 for (b)(4).

• Brand Name: 10MM/130 DEG TI CANN TFNA 360MM/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: 10169470
• Report Number: 2939274-2020-02891
• Device Sequence Number: 1762509
• Product Code: HSB
• UDI-Device Identifier: 10886982096135
• UDI-Public: (01)10886982096135
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.057S
• Device Catalogue Number: 04.037.057S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 06/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention