MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 38CM 125D RT; NAIL, FIXATION, BONE

Catalog Number 71675248

Device Problem Fracture (1260)

Patient Problems Ossification (1428); Failure of Implant (1924); Non-union Bone Fracture (2369); Unequal Limb Length (4534); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2021

Event Type  Injury  

Event Description

It was reported that an unknown trigen intertan nail fractured.It is unknown when this failure was observed relative to surgery and how the issue was resolved.Patient's health status is unknown.

Manufacturer Narrative

H6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A potential probable cause for this event could include but not limited to surgical technique.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.

Manufacturer Narrative

Internal reference number: (b)(4).Additional information was received by the manufacturer.The spaces corrected were: b1, b2, b3, b4 and h6 (health effect - clinical code & health effect - impact code).Internal reference number: (b)(4).

Event Description

It was reported that, after an open reduction with osteosynthesis had been performed on (b)(6) 2018 treat an intertrochanteric femoral neck multifracture, the patient experienced pseudoarthrosis with a nonunion of the treated femoral fracture, a right leg length discrepancy, anteflexion deformity and the fracture of the intertan 11.5mm x 38cm 125d rt along with the breakage of a proximal screw.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.During this procedure, the nail and screws were removed, and a hip joint replacement construct was implanted.The patient¿s outcome is unknown.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The end of the device is broken, rendering the device inoperative.A review of complaint history did not reveal similar events for the listed device.The clinical/medical evaluation concluded that the x-rays and revision operative note do confirm the reported fracture of the intertan nail, pseudarthrosis, right leg length discrepancy, anteflexion deformity, and breakage of the trigen screw.However, based on the limited information provided, the root cause of the reported events cannot be confirmed.It cannot be concluded that the reported clinical findings are associated with a malperformance of the implant, but could be related to the reported non-union.The patient impact beyond the revision cannot be determined.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.The manufacturing process of the device did not contribute to the reported event.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.Possible causes could include but are not limited to traumatic injury, patient anatomy or abnormal loading of limb.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.We consider this investigation closed.

• Brand Name: INTERTAN 11.5MM X 38CM 125D RT
• Type of Device: 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: 12373072
• MDR Text Key: 268321017
• Report Number: 1020279-2021-06554
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71675248
• Device Lot Number: 17MT96283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LAG/COM SCREW KIT 120/115 /71677120; TRIGEN LOW PROFILE SCREW 5.0MM X 42.5MM /71645042; TRIGEN LOW PROFILE SCREW 5.0MM X 50MM /71645050
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR