MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE L110 TAN; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.310S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient information is unknown.Date of event is unknown.Implant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant device is unknown.A device history record review was requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 the patient underwent removal of a trochanteric fixation nail advance (tfna) on (b)(6) 2018 due to helical blade cut out.One 110mm helical blade, one 5.0mm locking screw, and one cannulated nail were explanted.The hardware was originally implanted on an unknown date in early (b)(6) 2018.Patient walked too soon and the helical blade penetrated through the femoral head.A removal and a hemiarthroplasty were performed.The revision surgery was completed successfully with no complications and no time delay.Patient status following the procedure was reported as stable.Concomitant devices reported: 5.0mm locking screw (part # unknown, lot # unknown, qty: 1); 12mm cannulated nail (part # 04.037.261s, lot # h325954, qty: 1).(b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is a single use device but was not reprocessed or reused.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 L110 TAN
• 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: 7343110
• Report Number: 2939274-2018-51083
• Device Sequence Number: 2312007
• Product Code: HSB
• UDI-Device Identifier: 10886982099075
• UDI-Public: (01)10886982099075(17)270731(10)H421941
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.310S
• Device Catalogue Number: 04.038.310S
• Device Lot Number: H421941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 05/08/2018
• 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