MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/360MM/LT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.003.353S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record review was performed for the subject device: manufacturing location: (b)(4); manufacturing date: 15-aug-2013 ; expiration date: 30-apr-2022.Part #: 04.003.353s, lot#: 7383149 (sterile) ¿ 10mm ti lateral entry femoral recon nail-ex/360mm/lt - sterile.Quantity 6.Component parts reviewed: part 04.003.353s, 10mm ti lateral entry femoral lot: 7383149, meet specification.Sterile rework order requested on (b)(6) 2013 as per nonconformance (ncr).Nonconformance (ncr) was created for "space before lot# when scanned".This issue is not relevant to complaint condition.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.¿ 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 additional information is made available, the investigation will be updated as applicable.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 underwent a femoral nail removal on (b)(6) 2018 due to painful hardware.One 10mm ti lateral entry femoral recon nail-ex/360mm/lt-sterile and four 5.0mm titanium locking screws implanted on an unknown date (almost a year ago) were removed intact.Nothing was implanted after the removal of hardware.The procedure was completed without any delay and the patient was stable after the surgery.This is report 1 of 2 for (b)(4).

• Brand Name: 10MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/360MM/LT-STERILE
• 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: 7422897
• Report Number: 2939274-2018-51593
• Device Sequence Number: 10775389
• Product Code: HSB
• UDI-Device Identifier: 10886982082046
• UDI-Public: (01)10886982082046(17)220430(10)7383149
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 03/19/2018

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: 04/30/2022
• Device Model Number: 04.003.353S
• Device Catalogue Number: 04.003.353S
• Device Lot Number: 7383149
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/11/2018
• 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: 19 YR