MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM LCK 1/3 TUBULAR PL 6H 70MM; PLATE, FIXATION, BONE

Catalog Number	72440506
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, following a tibial orif procedure performed before (b)(6) 2020 to reduce a bicondylar tibial plateau fracture, one (1) patient developed an infected nonunion that required the removal of all hardware.The fracture was reportedly reduced at sixteen (12) postoperative weeks.No further information is available.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: 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: EVOS 3.5MM LCK 1/3 TUBULAR PL 6H 70MM
• Common Device Name: PLATE, 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: 19945178
• Report Number: 1020279-2024-01545
• Device Sequence Number: 7244859
• Product Code: HRS
• UDI-Device Identifier: 00885556639788
• UDI-Public: 885556639788
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

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 Catalogue Number: 72440506
• Device Lot Number: UNKNOWN
• 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: 08/01/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72403528/EVOS 3.5MM X 28MM CTX SCR S-T; 72403534/EVOS 3.5MM X 34MM CTX SCR S-T; 72403544/EVOS 3.5MM X 44MM CTX SCR S-T; 72403546/EVOS 3.5MM X 46MM CTX SCR S-T; 72403570/EVOS 3.5MM X 70MM CTX SCR S-T; 72403580/EVOS 3.5MM X 80MM CTX SCR S-T; 72413520/EVOS 3.5MM X 20MM LCK SCR S-T; 72413522/EVOS 3.5MM X 22MM LCK SCR S-T; 72440906/EVOS 3.5MM RECON PL 6H 66MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male