MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META RETRO FEM NAIL 10 X 38; NAIL, FIXATION, BONE

Model Number	71653038
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Osteomyelitis (4533)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
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 a surgical site infection and non-union after having a fracture fixation surgery of the right femur using the trigen retrograde femoral nail system.The patient was treated with surgical irrigation and debridement and wound vac.No hardware revision surgery was scheduled, and the patient was lost to follow up.It is unknown if the patient achieved bone union.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, h6 (health effect - clinical code).
Event or Problem Description
It was reported that the patient suffered from osteomyelitis of right leg polymicrobial hardware infection on (b)(6) 2017 and non-union with fever and purulent drainage after having a fracture fixation surgery of the right femur using the trigen retrograde femoral nail system on (b)(6) 2017.The patient was treated with surgical irrigation and debridement and wound vac.No hardware revision surgery was scheduled, and the patient was lost to follow up.It is unknown if the patient achieved bone union.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
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 information provided the reported symptoms (redness, pus, pain, and osteomyelitis) reported was due to a bacterial infection.This type of infection is a result of the procedure itself and not a malperformance of the smith and nephew devices.Consequently, we cannot determine if the bacterial contamination of the wound occurred during surgery or afterward due to the deterioration of skin barriers during the patient's wound care.In addition, the clinical root cause non-union itself is likely multifactorial due to the extent of the patient¿s multiple fractures with displaced fragments post-right open reduction and internal fixation along with the patient¿s age, smoking non-compliance, weight bearing and infection.It cannot be ruled out that the micro-motion of the non-union and the protruding second distal screw likely contributed to the patient¿s reported pain.Further impact to the patient beyond the reported osteomyelitis, non-union, bone stimulator, and pain could not be determined since the patient was lost to follow-up.For the meta retro femoral 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 meta retro femoral nail, a review of complaint history for the previous 32 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 32 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 reveals in the adverse events that infections, both deep and superficial can occur.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.For the meta retro femoral nail, a sterilization records review could not be performed as the batch number was not available.For the screws, a review of the sterilization records revealed the batches were sterilized within normal parameters.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: META RETRO FEM NAIL 10 X 38
• 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: 16014354
• Report Number: 1020279-2022-04984
• Device Sequence Number: 7334661
• Product Code: JDS
• UDI-Device Identifier: 03596010548207
• UDI-Public: 03596010548207
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 71653038
• Device Catalogue Number: 71653038
• 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; 10/10/2024
• 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 LOW PROFILE SCREW 5.0MM X 45MM; (B)(6)/TRIGEN LOW PROFILE SCREW 5.0MM X 77.5MM
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 62 KG