MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META RETRO FEM NAIL 11.5 X 40; NAIL, FIXATION, BONE

Model Number	71653240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from inflammatory reaction around the devices after having a fracture fixation surgery of the left femur using the trigen retrograde femoral nail system.The patient underwent an unplanned hardware removal on (b)(6) 2017.The patient achieved union at 27 weeks after the primary surgery.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 underwent a fixation surgery on (b)(6) 2016 after the patient sustaining a motor vehicle accident.The indication for this fixation surgery was a left distal tibia fracture, left closed distal femur fracture and left open segmental tibia fracture.The procedures performed were treatment of left tibia shaft fracture with intramedullary device, open treatment of distal tibia intra-articular fracture with fixation of tibia only, manual application of stress performed by physician or other qualified health care professional for joint radiography, left ankle, retrograde nailing of left femur, and irrigation and debridement of skin, subcutaneous tissue, muscle and bone of open left tibia fracture.During this surgery an unspecified plating system from smith and nephew was implanted, as well as a trigen femoral nailing system and a trigen tibial nailing system.The patient suffered from inflammatory reaction around the devices after having the primary surgery and underwent an unplanned hardware removal on (b)(6) 2017.The patient achieved union at 27 weeks after the primary surgery.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
H10.Additional information request: b5, d4, d10, h4.H11.Corrected information in h6 (health effect - impact code).
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 based on the information provided, an inflammatory reaction was the contributing factor to the reported unplanned hardware removal.We cannot confirm whether there was a hardware malfunction as the removal was post-union.The patient was impacted by cellulitis, and the device explantation.Since it was reported that the patient achieved union at 27 weeks after the primary surgery, no further clinical/medical assessment is required at this time.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 based on the historical data revealed a similar event for the listed batches, 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 irritational injury of soft tissues and tissue reactions which include macrophage and foreign body reactions adjacent to implants have been identified as possible adverse effects.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, patient condition or postoperative care.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 11.5 X 40
• 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: 16010542
• Report Number: 1020279-2022-04977
• Device Sequence Number: 6570411
• Product Code: JDS
• UDI-Device Identifier: 03596010548450
• UDI-Public: 03596010548450
• 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: 2016
• Device Explanted 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): 10/02/2024

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 Expiration Date: 04/05/2026
• Device Model Number: 71653240
• Device Catalogue Number: 71653240
• Device Lot Number: 16DM05112
• 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; 10/02/2024
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 08/24/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• 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: 71645032 / 16DM06790; 71645032 / 16DM06791; 71645035 / 16JM17085; 71645042 / 16KM04311; 71645060 / 16GM12698
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male