MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM TI SOLID FEMORAL NAIL 400MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	464.40S
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	11/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: (b)(6).Implanted in 2004; exact date is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4).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 implanted with a femoral nail in 2004 during an unknown procedure.Post-operatively, patient would return to surgery for a planned removal of the femoral nail for a total hip.During the planned explanation on (b)(6) 2017, the patient had an intertrochanteric fracture.The intact femoral nail and unknown number of screws were removed.A 2-hole dynamic hip system (dhs) was implanted with a lag screw and two (2) cortical screws for the fracture.There was a one (1) hour surgical delay due to difficulty getting the nail out.Procedure was completed successfully and patient status was reported as fine.This report is for one (1) 9mm ti solid femoral nail 400mm-sterile.(b)(4).
Additional Manufacturer Narrative
Manufacturing location: (b)(4).Manufacturing date: september 28, 2000.Expiration date: september 30, 2009.The inspection sheet and component part were reviewed and met specification.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.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: 9MM TI SOLID FEMORAL NAIL 400MM-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: 7113916
• Report Number: 2939274-2017-50257
• Device Sequence Number: 16618162
• Product Code: HSB
• UDI-Device Identifier: 10886982232366
• UDI-Public: (01)10886982232366(17)090930(10)4168284
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K923580
• 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,Followup
• Report Date (Section B): 11/15/2017

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 Expiration Date: 09/30/2009
• Device Model Number: 464.40S
• Device Catalogue Number: 464.40S
• Device Lot Number: 4168284
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 12/27/2017
• 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: 30 YR
• Patient Weight: 59