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
(b)(4).Device was used for treatment, not diagnosis.Unknown when non-union started.Additional product code: hwc original surgery date is unknown.Complainant part 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 review history: manufacturing location: (b)(4).Manufacturing date: 10-oct-2014.Expiration date: 31-aug-2023.Part #: 456.414s, lot#: 7812522 (sterile) - 11 mm/130 deg ti cann troch fixation nail 340 mm/right - sterile.Quantity 6.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.Investigation summary: product was not returned.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 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 had to undergo a revision surgery on an unknown date for removal one 5.0 mm distal locking screw in order to dynamize the construct to induce callus formation and subsequent healing as there was a delayed union.The patient was originally implanted with a tfn nail, a helical blade and one 5.0 mm distal locking screw for treatment of proximal femur fracture on (b)(6) 2015.The screw was removed intact and uneventfully.No other information is available.This complaint involves three (3) devices.This report is 2 of 3 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: 7286853
• Report Number: 2939274-2018-50699
• Device Sequence Number: 1316944
• Product Code: HSB
• UDI-Device Identifier: 10886982227805
• UDI-Public: (01)10886982227805(17)230831(10)7812522
• Combination Product (Y/N): N
• Initial Reporter State: OR
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2018

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: 01/24/2018
• Initial Report FDA Received Date: 02/21/2018
• 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