MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/360MM/RT-STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.031.976S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Part # 04.031.976s, synthes lot # h437000, supplier lot # n/a, release to warehouse date: 22aug2017, expiration date: 31jul2022, manufactured by: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Customer quality investigation: the femoral nail was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, no fault or issue could be identified and confirmed.A dhr review was conducted based on the given lot number and showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.However, the part and lot number cannot be confirmed from the image of the device.Conclusion: product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.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.Health effect clinician code (b)(4) used to capture injury.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 on (b)(6) 2021, the patient underwent a hardware removal procedure of ex adolescent nail on the right femur.This report involves one (1) ø10mm ti adolescent lat entry femoral nail-ex/360mm/rt-ster.This is report 1 of 5 for (b)(4).

• Brand Name: 10MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/360MM/RT-STER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12253921
• Report Number: 2939274-2021-04362
• Device Sequence Number: 2885683
• Product Code: HSB
• UDI-Device Identifier: 10886982094704
• UDI-Public: 10886982094704
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K070843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: 07/31/2022
• Device Model Number: 04.031.976S
• Device Catalogue Number: 04.031.976S
• Device Lot Number: H437000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/30/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR