MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 11.5MM X 42CM RIGHT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71640742
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an internal fixation, one (1) meta-tan 11.5mm x 42cm right was inserted in the usual matter, however after removing the jig, it was discovered that the integrated screw had missed, anterior to the nail.It was advised that it was a complicated case.Note that the jig was aligned prior to and once again after the case.The procedure was resumed, after a non-significant delay, with a competitor product.No further information available at the moment.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.However, the photographs were reviewed and revealed that a guide pin sleeve with a guide pin positioned inside the screw hole of the nail.However, through this inspection it can not be confirmed the correct alignment.The nail has damage more than likely from the surgical procedure.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 intramedullary nail system reveals in the preoperative planning that proper reduction of fractures and proper placement of implants are necessary to effectively treat patients using metallic surgical implants.Also according to the surgical technique for trigen meta-tan the targeting accuracy should be verified, for the integrated screw mode the drill guide drop should be attach to the drill guide to verify targeting accuracy, then insert the lag screw drill sleeve into the drill guide drop and pass the lag screw drill through the lag screw drill sleeve and nail.An incorrectly attached nail will not target.With targeting accuracy confirmed, remove the drop and any drill sleeves.It is important to do not definitively seat the nail until femoral neck anteversion has been determined.Further insertion of the nail may be required to adequately seat the implant.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.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.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.

• Brand Name: META-TAN 11.5MM X 42CM 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: 19785046
• Report Number: 1020279-2024-01411
• Device Sequence Number: 18212539
• Product Code: HSB
• UDI-Device Identifier: 00885556341490
• UDI-Public: 00885556341490
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (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): 08/16/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71640742
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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