MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META RETRO FEM NAIL 10 X 36; NAIL, FIXATION, BONE

Model Number	71653036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/15/2021
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 non-union and knee pain after having a fracture fixation surgery of the right femur using the trigen retrograde femoral nail system.The patient underwent a revision surgery to exchange the nail on (b)(6) 2021.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: d4, d10, h4.
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 x-ray images were provided for review and confirm the reported.The clinical root cause for the reported pain and revision surgery was the result of nonunion.There is no evidence to support that there was a device malfunction of the smith and nephew device.The patient impact is the revision, and a brief post-operative recovery phase would be anticipated.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed devices over the previous 32 months, but no similar events for the batches based on the historical data, 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 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.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.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 product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues and/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: META RETRO FEM NAIL 10 X 36
• 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: 16015965
• Report Number: 1020279-2022-05002
• Device Sequence Number: 17590858
• Product Code: JDS
• UDI-Device Identifier: 03596010548191
• UDI-Public: 03596010548191
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2024

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: 71653036
• Device Catalogue Number: 71653036
• Device Lot Number: 19CT17927
• 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; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• 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 32.5MM.; (B)(6)/TRIGEN LOW PROFILE SCREW 5.0MM X 35MM.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male