MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LM/RL TIBIA RESECTION GUIDE STANDARD; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	74036106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after uka surgery had been performed on (b)(6) 2024, approximately 2 weeks after the primary surgery, x-rays showed a tibial fracture in the hole where the lm/rl tibia alignment guide retention pin was inserted.This adverse event was treated by additional surgery to implant a plate on (b)(6) 2025.The surgeon believes that the location of the pin hole associated with the use of the device caused the fracture.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates 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.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the x-rays of the female patient showed a tibial fracture in the hole where the tibial alignment guide retention pin was inserted which required additional surgery.The electronic photocopied x-rays were reportedly at 1 week and 2 weeks post-uka with a post-plating performed about 3.5 weeks post uni-knee and appear to show an obvious spherical-shaped anteromedial tibial pin hole then what appears to be a pin-hole change oblique/collapse/fracture followed by tibial plating, respectively.The surgical technique of the device recommends use of a headed rimmed pin to secure the extramedullary guide assembly to the anterior proximal tibia once provisional alignment is established.Additionally, it is noted that stress concentrations caused by undercutting the tibial plateau and spine may increase the risk of post-operative bony fracture.The current patient health status is unknown.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.A clinical root cause could not be concluded.It is unknown if the recommended headed rimmed pin was used and if a single pin was sufficient to secure the extramedullary guide/provided enough stabilization, or if the undercut pin was implemented.Without the requested operative documentation, the user technique and/or pin utilization cannot be ruled out as potential contributing factors to the post-uni anteromedial tibial fracture.Impact: the patient impact includes the anteromedial tibial fracture and subsequent plating within a month of the uni-knee implantation.Further impact cannot be determined; however, a transient post-surgical restorative phase would be anticipated.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for unicompartmental knee systems revealed that this has been identified as a tibia fractures have been identified as adverse reactions.A review of the risk management file 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 this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the device or 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.Corrected data: e1 (address), g2.

• Brand Name: LM/RL TIBIA RESECTION GUIDE STANDARD
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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: 21252174
• Report Number: 1020279-2025-00174
• Device Sequence Number: 8093475
• Product Code: FZX
• UDI-Device Identifier: 00885556696354
• UDI-Public: 885556696354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2025

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: 74036106
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: Not provided; 03/04/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/03/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 74026024 / LOT: UNKNOWN; PN: 74026159/ LOT: UNKNOWN; PN: 74026714 / LOT: UNKNOWN; PN: 74036104 / LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 55 KG