MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAN ROSE 10 X 38 RT; NAIL, FIXATION, BONE

Catalog Number	71635238
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from trochanteric bursitis with pain over the screws after having a fracture fixation surgery of a left femur fracture on (b)(6) 2016 using the trigen tan system.The patient underwent steroid injection (b)(6) 2019.The patient achieved union at 58 weeks after the primary procedure.The current state of health of the patient is unknown.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: this complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided images show a consolidated femoral fracture, but the heads of the femoral neck screws are at the region which may interfere with the trochanteric bursa, therefore it is reasonable that the bursitis is related to their placement.The patient tenderness to palpation over right recon screw heads is consistent with the diagnosed trochanteric bursitis.Trochanteric bursitis is a known complication of hip surgery and is related to the surgery and not the implant.The patient impact is determined to be the steroid injection.Devices' batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the nail and hex screw over the past 28 months did not reveal similar events for the listed devices.A review of complaint history revealed similar events for the low profile screws over the previous 28 months, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for intramedullary nail system revealed that tissue reactions which include macrophage and foreign body reactions adjacent to implants can occur.This has been identified as an adverse event.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness or patient condition.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FAN ROSE 10 X 38 RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20054722
• Report Number: 1020279-2024-01654
• Device Sequence Number: 7977910
• Product Code: JDS
• UDI-Device Identifier: 03596010393395
• UDI-Public: 03596010393395
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K210980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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 Catalogue Number: 71635238
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71642390/INT HEX RC SCR BL 6.4X90.; 71645035/TRIGEN LOW PROFILE SCREW 5.0MM X 35MM.; 71645042/TRIGEN LOW PROFILE SCREW 5.0MM X 42.5MM.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Race: White