MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 10MM X 37CM; NAIL, FIXATION, BONE

Catalog Number	71655137
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 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
Internal complaint reference: (b)(4).H3, h6: 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.

• Brand Name: META-NAIL TIBIAL 10MM X 37CM
• 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: 20058825
• Report Number: 1020279-2024-01660
• Device Sequence Number: 20912300
• Product Code: JDS
• UDI-Device Identifier: 03596010585592
• UDI-Public: 3596010585592
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2024

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
• Device Expiration Date: 04/21/2026
• Device Catalogue Number: 71655137
• Device Lot Number: 16DSM0230
• 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
• Initial Report FDA Received Date: 08/24/2024
• Date Device Manufactured: 04/18/2016
• 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: PN: 71645032 / LN: 16DM06790; PN: 71645032 / LN: 16DM06791; PN: 71645035 / LN: 16JM17085; PN: 71645042 / LN: 16KM04311; PN: 71645060 / LN: 16GM12698
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male