MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 80MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.280S
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
Date of event: unknown, complainant device is not expected to be returned for manufacturer review/investigation.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) tfna helical blade 80mm sterile.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Sterile part 04.038.280s, lot h265334: manufacturing location: (b)(4).Manufacturing date: january 23, 2017.Expiration date: december 31, 2026.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 80mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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: TFNA HELICAL BLADE 80MM 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: 7084289
• Report Number: 2939274-2017-50144
• Device Sequence Number: 13774953
• Product Code: HSB
• UDI-Device Identifier: 10886982098955
• UDI-Public: (01)10886982098955(17)261231(10)H265334
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• 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 Model Number: 04.038.280S
• Device Catalogue Number: 04.038.280S
• Device Lot Number: H265334
• 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