MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.418S
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.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 11mm/130 deg ti cann troch fixation nail.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A device history record (dhr) review was conducted: manufacturing location: monument: manufacturing date: 06-mar-2015, expiration date: 31-jan-2024: part number: 456.418s, lot number: 7931186 (sterile), lot quantity (b)(4): 11mm/130 deg ti cann troch fixation nail 380mm/right- sterile: work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance, met all inspection acceptance criteria.Inspection sheet, inspect dimensional, met all inspection acceptance criteria.Inspection sheet, final inspection, met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev m was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn (sterilization control number) supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: 456.314.3, lock driver tfn, bp55, lot number: 7768925, lot quantity: (b)(4): work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final, 456fi314-3 rev h met all inspection acceptance criteria.456.315.2, 130 degree lock prong tfn, bp58; lot number: 7929584; lot quantity: (b)(4): work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance sheet, op045442 rev a met all inspection acceptance criteria.Inspection sheet ns043861 rev f met all inspection acceptance criteria.21069, tialnbri18.00, bp80; lot number: 7790624; lot quantity: (b)(4).: certificate of test received from ati allvac dated 22-aug-2014 was reviewed and determined to be conforming.Lot summary report dated 05-sep-2014 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.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: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER
• 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: 7970602
• Report Number: 2939274-2018-54411
• Device Sequence Number: 16496801
• Product Code: HSB
• UDI-Device Identifier: 10886982227843
• UDI-Public: (01)10886982227843
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• 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,Followup
• 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 Expiration Date: 01/31/2024
• Device Model Number: 456.418S
• Device Catalogue Number: 456.418S
• Device Lot Number: 7931186
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/19/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention