MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAN LIME {} 10 X 40 LF; NAIL, FIXATION, BONE

Model Number	71634240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Nonunion/Delayed-union Bone Fracture (2369); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from fracture non-union after having a fracture fixation surgery of the left femur using the trigen fan system.The patient underwent a revision surgery on (b)(6) 2019 with exchange of the nailing system to a competitor´s system.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; therefore, additional information is not known, and it is not possible to collect it.We do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.
Additional Manufacturer Narrative
Internal reference number: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from a post market clinical follow up activity sponsored by smith and nephew.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.
Event or Problem Description
It was reported that the patient suffered from fracture non-union on (b)(6) 2019 after having a fracture fixation surgery of the left femur using the trigen fan system on (b)(6) 2018.The patient underwent a revision surgery on (b)(6) 2019 with exchange of the nailing system to a competitor´s system.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; therefore, additional information is not known, and it is not possible to collect it.We do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.
Additional Manufacturer Narrative
Additional information: a4, b3, b5, d10.
Additional Manufacturer Narrative
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 based on the x-ray findings from (b)(6)2019, the increased callus between proximal shaft and large butterfly fragment in the lateral soft tissue, we cannot rule out inadequate fracture reduction, nail selection, the high-impact trauma, non-compliance, and the language barrier as the likely causes of the reported non-union, clicking, popping, pain and the subsequent revision.Therefore, it could not be concluded that these adverse events were a mal-performance of the implant or an implant failure.Additionally, a user error versus procedural variance could not be ruled out as the likely cause of the intra-operative drill tip and proximal non-locking screw breakage in the patient's bone in the revision procedure.The material composition of the retained (manufacturer unknown) drill bit is unknown.However, drill bits are externally communicating devices that are not designed for implantation and long-term implantation data is not available.The reported stated that the drill bit was ¿buried in the bone,¿ therefore, micro-motion and migration is unlikely.However, we cannot determine the impact of the non-implantable foreign body.The fractured implantable competitor¿s synthes proximal non-locking screw was retained in the bone; therefore, micro-motion and migration is unlikely.Further impact to the patient beyond the reported non-union, pain, popping, clicking, bone stimulator, revision, retained drill bit, retained screw, and permanent partial disability rating: left femur and knee: (b)(4), could not be assessed because the patient¿s current status is unknown.For the femoral antegrade nail, device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For the screws, a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the femoral antegrade nail, a review of complaint history for the previous 24 months did not reveal similar events for the listed device.For the screws, a review of complaint history for the part numbers over the past 24 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for intramedullary nail system revealed that care prior to bony union stablish to immobilize and/or externally support skeletal structures that have been implanted with surgical metallic implants until skeletal union is observed.Early weight bearing substantially increases implant loading and increases the risk of loosening, bending or breaking the device.Early weight bearing should only be considered where there are stable fractures with good bone-to-bone contact.Patients who are obese and/or noncompliant, as well as patients who could be pre-disposed to delayed or non-union, should have auxiliary support.The implant may be exchanged for a larger, stronger nail subsequent to the management of soft tissue injuries.Patients and nursing care providers should be advertised of these risks.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.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 LIME {} 10 X 40 LF
• 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: 16014722
• Report Number: 1020279-2022-04988
• Device Sequence Number: 6561653
• Product Code: JDS
• UDI-Device Identifier: 03596010393289
• UDI-Public: 03596010393289
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K981529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71634240
• Device Catalogue Number: 71634240
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 08/22/2024; 10/11/2024
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 08/23/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: (B)(6)/TRIGEN INTERNAL HEX CAPTURED RECON SCREW; (B)(6)/TRIGEN INTERNAL HEX CAPTURED RECON SCREW; (B)(6)/TRIGEN LOW PROFILE SCREW 5.0MM X 45MM; (B)(6)/TRIGEN LOW PROFILE SCREW 5.0MM X 57.5MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 74 KG