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

Model Number	04.038.195S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Impaired Healing (2378); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review / investigation but has yet to be received.Additional pro-code: ktt.Without a lot number the device history records review could not be completed.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 revision surgery due to a broken trochanteric femoral nailing system advanced (tfna) fenestrated screw and distal locking screw on (b)(6) 2019.Originally, the patient was implanted with the tfna due to a right proximal femur fracture in (b)(6) 2018.On an unknown date after the original surgery, the patient presented for treatment of non-union of right proximal femur.The threaded portion of the lag screw broke deep within the bone and a decision was made to leave it.Additionally, the distal locking screw was also found broken and a decision was also made to not retrieve the fragments.The nail and a majority of the lag screw were removed and replaced with an angle blade plate.The implants and specimens were sent to pathology for routine culture and rule out infection.However, the suspected cause of the non-union was a poor reduction from the original surgery.The surgery was successfully completed with no adverse consequence to the patient.Concomitant device reported: tfna nail (part # 04.037.158s, lot # unknown, quantity# 1).This is report 2 for 2 (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.A product investigation was completed: the device was not returned.A provided fluoroscopy/x-ray image was reviewed.The image revealed a portion of the threaded distal tip of a broken lag screw within the patient's femoral head.The remaining portion of the lag screw was not implanted and not visible in the image.No issues were observed to the concomitant nail.The distal locking screw was not visible in the image provided.No other devices or issues were noted in the image.The device's lot number remained unknown.Therefore, a manufacturing record evaluation/review could not be performed.The complaint was confirmed with investigation.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the reported event.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 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: TFNA FENESTRATED SCREW 95MM - 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: 8961320
• Report Number: 2939274-2019-60298
• Device Sequence Number: 11426594
• Product Code: HSB
• UDI-Device Identifier: 10886982098757
• UDI-Public: (01)10886982098757
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.195S
• Device Catalogue Number: 04.038.195S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/16/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE; 11 MM/130 DEG TI CANN TFNA 380 MM/RIGHT - STERILE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 66 YR
• Patient Weight: 88