MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT-STER; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.414S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Date of event is unknown.Additional classification code: hwc complainant part is not expected to be returned for manufacturer review/investigation.A device history record review was performed for the subject device manufacturing location: (b)(6), manufacturing date: 10-oct-2014.Expiration date: 31-aug-2023.Part #: 456.414s, lot#: 7812522 (sterile) - 11mm/130 deg ti cann troch fixation nail 340mm/right - sterile.Quantity 6.Component parts reviewed: 456.314.3 - trochanteric fixation nail lock driver tfn, bp 55, lot 7676690; 456.315.2 - trochanteric fixation nail lock 130 deg lock prong tfn, bp 58, 7803351; 21069 - raw material lot bp-80 lot - 7698921 received from supplier (b)(6).(b)(6) certificate of test for titanium meets specification.Raw material receiving/put away checklist meet requirements.Inspection sheet for inspect dimensional (b)(4), final inspection (b)(4), met inspection acceptance criteria.No ncrs were generated during production.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.Scn: ¿sterility documentation was reviewed and determined to be conforming.¿ 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 a patient will have to undergo a revision surgery on (b)(6) 2018 for removal of a tfn nail, a helical blade and one 5.0mm distal locking screw due to non-union.The hardware was implanted for treatment of proximal femur fracture on (b)(6) 2015.The revision surgery took place on (b)(6) 2018.It was an exchange nailing for nonunion of an atypical subtrochanteric femur fracture.One 11mm/130 deg ti cann troch fixation nail 340mm/right-ster and 11.0mm ti helical blade 85mm were removed intact without any complication.After the removal of the hardware, another 14mm/130 deg ti cann troch fixation nail 340mm/right-ster, one 11.0mm ti helical blade 85mm and one 5.0mm ti locking screw 48mm-for im nails were implanted in the patient.Additionally, the surgeon used bone marrow aspirate concentrate and cancellous chip graft.The patient was stable after the surgery.There was no surgical delay and the procedure was completed successfully.As per the sales consultant the 5.0mm distal locking screw implanted on (b)(6) 2015 was removed during a intervening surgery done on an unknown date between (b)(6) 2015 and (b)(6) 2018 in an attempt to dynamize the construct to induce callus formation and subsequent healing.This is report 1 of 2 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/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: 7253268
• Report Number: 2939274-2018-50561
• Device Sequence Number: 1031808
• Product Code: HSB
• UDI-Device Identifier: 10886982227805
• UDI-Public: (01)10886982227805(17)230831(10)7812522
• Combination Product (Y/N): N
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2018

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: 08/31/2023
• Device Model Number: 456.414S
• Device Catalogue Number: 456.414S
• Device Lot Number: 7812522
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/08/2018
• 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