MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 36CM 125D RT; NAIL, FIXATION, BONE

Model Number	71675224
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032); Discomfort (2330); Ambulation or Postural Difficulties (2544)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery had been performed on (b)(6) 2015 in order to treat a comminuted femur fracture, the patient experienced a rupture of the intertan 10mm x 36cm 125d rt used.Functional discomfort with persistent limp and proximal right hip impingement were reported.A revision surgery was performed on (b)(6) 2021 in order to remove the broken centromedullary nail.Also, an isolated bone grafting was performed as the fracture was consolidated.The device is not available for analysis.The current health status of the patient is unknown.
Event or Problem Description
It was reported that, after an internal fixation surgery had been performed on (b)(6) 2015 in order to treat a comminuted femur fracture, the patient experienced a rupture of the intertan 10mm x 36cm 125d rt used.Functional discomfort with persistent limp and proximal right hip impingement were reported.The diagnostic was performed on (b)(6) 2021, and on (b)(6) 2021 a revision surgery was performed in order to remove the broken centromedullary nail.Also, an isolated bone grafting was performed as the fracture was consolidated.The device is not available for analysis.The postoperative period was satisfactory and the patient was sent to follow-up and rehabilitation care.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that no relevant clinical information or the device has been provided for inclusion in this medical investigation.Therefore, a thorough medical investigation cannot be rendered nor can the clinical root cause be determined.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional clinically relevant documentation be provided, this complaint would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal similar events for the listed device.A review of the risk management file and instructions for use documents 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 reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: INTERTAN 10MM X 36CM 125D RT
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13282441
• Report Number: 1020279-2022-00255
• Device Sequence Number: 4933346
• Product Code: JDS
• UDI-Device Identifier: 03596010561091
• UDI-Public: 03596010561091
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 71675224
• Device Catalogue Number: 71675224
• Device Lot Number: 13EM01682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 02/01/2022; 02/16/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/08/2022; 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2013
• 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
• Patient Sex: Unknown