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

Model Number	04.037.056S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4) is used to capture required medical/surgical intervention as the patient's femoral head collapsed into varus and required a hemi-arthroplasty.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 on (b)(6)2017 patient presented to the emergency room with a intertrochanteric hip fracture.The fracture was confirmed with x-rays.The surgeon took the patient to the operating room on (b)(6) 2017 and patient was implanted with a long trochanteric fixation nail advance (tfna) nail with helical blade and distal locking screws.On (b)(6) 2017, an x-ray during normal follow up showed the femoral head starting to slightly collapse.The surgeon elected to wait and watch the fracture.X-ray on (b)(6) 2017 showed further collapse of the head into varus.On (b)(6) 2017, surgeon took the patient back to the operating room to remove the tfna nail, the tfna helical blade, and two locking screws and took cultures.None of the implants were broken and the removal was a success.A hemi-arthroplasty was performed in place of the hardware removal.Concomitant parts: 5.0mm ti locking screw with t25 strardrive 40mm f/im nail (part number: 04.005.530s, lot number: h359595, quantity 1), 5.0mm ti locking screw with t25 stardrive 38mm f/im nail (part number: 04.005.528s, lot number: h329932, quantity 1).This report is for one (1) 10mm/130 degree ti cannulated tfna 360mm/right - sterile.This is report 1 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Sterile part 04.037.056s, lot h149887: manufacturing location: (b)(4).Manufacturing date: august 04, 2016.Expiration date: june 30, 2026.Component parts and raw material was reviewed and met specification.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: 10MM/130 DEG TI CANN TFNA 360MM/RIGHT - 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: 7084307
• Report Number: 2939274-2017-50143
• Device Sequence Number: 13648356
• Product Code: HSB
• UDI-Device Identifier: 10886982096128
• UDI-Public: (01)10886982096128(17)260630(10)H149887
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 11/07/2017

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: 06/30/2026
• Device Model Number: 04.037.056S
• Device Catalogue Number: 04.037.056S
• Device Lot Number: H149887
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 12/29/2017
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 01/02/2018
• 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 Weight: 78