MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 11.5MM X 38CM; NAIL, FIXATION, BONE

Model Number	71655238
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a trigen tibial meta-nail 11.5 x 38 broke at proximal tip of nail.The pieces were retrieved with a forceps.The procedure was completed with a back up device.No other injuries were reported and no significant delays.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.From the analysis conducted during this investigation, it was concluded that the meta-nail tibial 11.5mm x 38cm nail fractured by the initiation and subsequent propagation of shear forces.The fracture likely initiated on the anterior side of the nail through the most proximal hole.The shear forces quickly propagated in a quasi-static manner to an extent that the cross-sectional area of the nail could not bear the imposed loading, which led to an overload fracture of the nail.No material deviations were found during this investigation.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device broke and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.Some potential probable causes for this event could include but not limited to surgical technique or excessive forces applied to the implant.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.

• Brand Name: META-NAIL TIBIAL 11.5MM X 38CM
• Common Device Name: NAIL, 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 ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11478940
• Report Number: 1020279-2021-02100
• Device Sequence Number: 14310315
• Product Code: JDS
• UDI-Device Identifier: 03596010585691
• UDI-Public: 03596010585691
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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 Model Number: 71655238
• Device Catalogue Number: 71655238
• Device Lot Number: 19MSM0104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2019
• 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: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown