MAUDE Adverse Event Report: SYNTHES (U.S.A) LP TFN-ADVANCE (10886982096685); TITANIUM FIXATION NAIL

Model Number	04.037.160S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Six weeks post a intramedullary mailing for a right subtrochanteric femur fracture patient felt a sudden pain in right hip while walking.Upon examination he was noted to have failure of his hardware proximally with the nail appearing to have broken where the helical blade passes through it.

• Brand Name: TFN-ADVANCE (10886982096685)
• Common Device Name: TITANIUM FIXATION NAIL
• Manufacturer (Section D): SYNTHES (U.S.A) LP; monument CO
• MDR Report Key: 5956296
• Report Number: 5956296
• Device Sequence Number: 18975052
• Product Code: HRS
• UDI-Device Identifier: 10886982096685
• UDI-Public: 10886982096685
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/21/2016
• Report Date (Section F): 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 04.037.160S
• Device Catalogue Number: 04037160S
• Device Lot Number: 9859838
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2016
• Event Location: Home
• Date Report to Manufacturer: 07/21/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 95