MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 11.5MM X 40CM RIGHT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71640740
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an internal fixation surgery, the meta-tan lag/comp kit 75/70 missed the meta-tan 11.5mm x 40cm right by approximately 90 degrees.Nail was removed and attached to jig and "although some movement, nowhere near enough to miss the nail with the screws".Additional holes had to be made, confirmed jig gave the correct trajectory.There was a delay greater than 30 minutes and the procedure was finished using an intertan nail instead.Patient was not harmed.
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: d10 (concomitant lag/compression screw kit added).Corrected data: h6 (health effect - impact code).Updated results of investigation: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The provided image shows the lag and compression screws are not engaged in the proximal screw holes of the metatan nail.Based on the limited information provided, a definitive root cause cannot be concluded; however, it is likely that a user technique/variance contributed to the reported event since after the metatan nail was explanted ¿it was confirmed the jig did give the correct trajectory¿.The patient impact is determined to be the implantation of ¿missed¿ screws followed by removal of the metatan nail with replacement using an intertan system during the same surgery, the additional femoral head bone holes and the reported greater than 30-minute surgical extension.It is unknown if the additional intertrochanteric bone holes may contribute to an increased risk for delayed healing or weakened construct.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 for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.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.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.

• Brand Name: META-TAN 11.5MM 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: 20952336
• Report Number: 1020279-2024-02689
• Device Sequence Number: 8196085
• Product Code: HSB
• UDI-Device Identifier: 00885556341445
• UDI-Public: 885556341445
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092748
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71640740
• Device Lot Number: 22FM16219
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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: 71642675 / LOT: 23AT70888
• Patient Sex: Unknown