MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.195
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).Additional pro-code: ktt.Investigation summary: background: it was reported that on an unknown date, during an orthopedic procedure, after the tfna implanted on 4/19/2021, the femur was broken below distal interlocking screw in nail.Nail, lag screw, and distal interlocking screw were removed on 5/29/2021 and swapped out with new tfna exchange nail, lag screw and new interlocking screw distally.The procedure successfully completed.Patient outcome is unknown.This complaint involves three (3) devices.Customer quality investigation: the device was not returned.A photo-investigation was performed on the images located in pc attachment ¿tfn nail 5.29.2021.Jpg", ¿img_7894.Jpg¿, ¿femur fracture 5.29.2021.Jpeg¿, and ¿lag screw 5.29.2021.Jpg¿.Upon inspecting the images provided, no issues were noted with the implant(s) that would contribute to the adverse event and therefore is unconfirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition could not be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot16-jun-2021 a dhr review was not performed for this pi.This part number is manufactured by elmira.Please reassign this task to the correct group.16-jun-2021 part number: 04.038.195-us.Lot number: 77p7816.Part manufacture date: 19-nov-2020 manufacturing location: (b)(4).Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated screw 95mm - sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history batch null, device history review this lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 an unknown date, during an orthopedic procedure, after the tfna implanted on (b)(6) 2021, the femur was broken below distal interlocking screw in nail.Nail, lag screw, and distal interlocking screw were removed on (b)(6) 2021 and swapped out with new tfna exchange nail, lag screw and new interlocking screw distally.The procedure successfully completed.Patient outcome is unknown.This complaint involves three (3) devices.This report is for one (1) tfna fenestrated screw 95mm.This report is 2 of 3 for (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 95MM
• 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: 12060538
• Report Number: 2939274-2021-03196
• Device Sequence Number: 4203092
• Product Code: HSB
• UDI-Device Identifier: 10886982098740
• UDI-Public: (01)10886982098740
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2021

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 Model Number: 04.038.195
• Device Catalogue Number: 04.038.195
• Device Lot Number: 77P7816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 82