MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 13MM X 40CM RIGHT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71640840
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation performed on (b)(6) 2024, a (1) meta-tan 10mm x 40cm right broke inside the patient on (b)(6) 2024.This adverse event was solved by revision surgery on (b)(6) 2024 in which the meta-tan 10mm x 40cm right was explanted and the patient went through a competitor total hip replacement.Patient's status is unknown.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or 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 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 submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Additional information: d4 (expiration date), h4 corrected data: b5, d1, d4 (catalog number, unique identifier (udi) #).
Event or Problem Description
It was reported that, after an internal fixation performed on (b)(6) 2024, a (1) meta-tan 13mm x 40cm right broke inside the patient on (b)(6) 2024.This adverse event was solved by revision surgery on (b)(6) 2024 in which the meta-tan 13mm x 40cm right was explanted and the patient went through a competitor total hip replacement.Patient's status is unknown.No further complications were reported.

• Brand Name: META-TAN 13MM X 40CM RIGHT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 21102515
• Report Number: 1020279-2025-00073
• Device Sequence Number: 21037339
• Product Code: HSB
• UDI-Device Identifier: 00885556342541
• UDI-Public: 885556342541
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K243364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71640840
• Device Lot Number: 23GM16841
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown