MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 110MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.410
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
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on an unknown date, the patient underwent an open reduction and internal fixation surgery of proximal femur due to femur fracture.The plan was to implant a trochanteric fixation nail-advanced (tfna).When it came time to implant the nail, the nurse left the room to get a trochanteric fixation and a nail.Upon her return she had a tfn instead of a tfna and the nail was implanted.A new type of helical blade was implanted along with a tfn.The procedure was successfully completed.There was no surgical delay.The patient is stable and doing fine.This complaint involves two (2) device.This complaint is for (1) tfna fenestrated helical blade 110mm.This report is 2 of 2 for (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 110MM
• 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: 7970600
• Report Number: 2939274-2018-54414
• Device Sequence Number: 16193327
• Product Code: HSB
• UDI-Device Identifier: 10886982099327
• UDI-Public: (01)10886982099327
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.038.410
• Device Catalogue Number: 04.038.410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/16/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention