MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/420MM/LT; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.003.465S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.Date of event is unknown.Date of implant is unknown date one year ago.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.A device history record review has been requested.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 a revision of a femoral shaft fracture on (b)(6) 2018 due to nonunion.The patient was initially implanted with an expert lateral femoral on an unknown date a year ago.The surgeon removed the nail and screws and inserted an expert retrograde/antegrade femoral nail (r/afn).The revision was completed successfully with no complications and the patient status was reported as stable.This report is for a 11mm ti lateral entry femoral recon nail-ex/420mm/lt.This is report 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.Manufacturing location: monument; manufacturing date: 12-jan-2009; expiration date: 31-dec-2017; part #: 04.003.465s, lot#: 6055985 (sterile) ¿ 11mm ti lateral entry femoral recon nail-ex/420mm/lt - sterile.Quantity 6.Part met dimensional criteria.Component parts reviewed: part 21014, lot: 5399518 meet specifications.Raw material for titanium was received from dynamet incorporated.Product certification was received from dynamet and raw material receiving/putaway checklist meet specification.No nonconformances (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.Sterility documentation was reviewed and determined to be conforming.Investigation summary: it was reported that the patient underwent a revision of a femoral shaft fracture on (b)(6) 2018 due to nonunion.The patient was initially implanted with an expert lateral femoral on an unknown date a year ago.The surgeon removed the nail and screws and inserted an expert retrograde/antegrade femoral nail (r/afn).The revision was completed successful with no complications and the patient status was reported as stable.The following investigation flow was performed: adverse event (no reported product problem).No device was returned for investigation.Visual inspection of one photo provided by the sales consultant was performed at customer quality (cq) and was unable to confirm the condition of a non-union, which does not agree with the reported complaint condition.No x-rays showing a non-union were provided, the only photo provided was of the proximal region of the nail with part#/lot# identifiers.No damage to the device was observed in the photo.Therefore this complaint was unable to be confirmed.The complaint device was manufactured in december 2017.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.This complaint is not confirmed and no product design issues or manufacturing discrepancies were identified during this investigation.There is no allegation of device defect, deficiency or surgical technique error associated with this complaint.As there is no device malfunction alleged and no associated surgical technique error, a design and clinical risk management (dcrm) review will not be completed as it is outside of the scope of the dcrm.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 TI LATERAL ENTRY FEMORAL RECON NAIL-EX/420MM/LT
• 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: 7503215
• Report Number: 2939274-2018-52124
• Device Sequence Number: 16184900
• Product Code: HSB
• UDI-Device Identifier: 10886982082305
• UDI-Public: (01)10886982082305
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040336
• 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): 04/19/2018

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: 12/31/2017
• Device Model Number: 04.003.465S
• Device Catalogue Number: 04.003.465S
• Device Lot Number: 6055985
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/15/2018
• 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
• Patient Age: 48 YR