MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 9MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/380MM/LT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.003.257S
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
Patient identifier, date of birth, and weight not available for reporting.Date of non-union is not known.(b)(4).Date of implant reported as (b)(6) 2015.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.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 a patient was treated with a 9 mm x 380 mm synthes lateral entry femoral nail (lefn) for a femur fracture on an unknown date in (b)(6) 2015.On a subsequent unknown date, the surgeon determined that the patient had a delayed non-union of the femur.On (b)(6) 2017, the patient was returned to the operating room for hardware removal and revision to a longer 11 mm x 380 mm lefn nail.There was no reported surgical delay, no broken hardware or fragments, and the surgery was completed successfully.This is report 1 of 2 for (b)(4).

• Brand Name: 9MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/380MM/LT-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: 7145661
• Report Number: 2939274-2017-50415
• Device Sequence Number: 927141
• Product Code: HSB
• UDI-Device Identifier: 10886982081865
• UDI-Public: (01)10886982081865(17)EXPIRATIONUNKNOWN(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K040336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2017

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: 04.003.257S
• Device Catalogue Number: 04.003.257S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/26/2017
• 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: 22 YR