MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX38CM 125D LT; NAIL, FIXATION, BONE

Catalog Number 71676557

Device Problem Fracture (1260)

Patient Problems Anemia (1706); Failure of Implant (1924); Muscle Weakness (1967); Pain (1994); Deformity/ Disfigurement (2360); Non-union Bone Fracture (2369)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).(b)(4) --- this report is related to the breakage of the nail.(b)(4) --- this report is related to the breakage of the screw.Both reports refer to the same patient and adverse event.

Event Description

It was reported that, a plaintiff underwent a left intertan femoral nail procedure, on (b)(6) 2023, due to a fall and subsequent sub trochanteric fracture.They later developed a varus deformity and were diagnosed with a sub trochanteric / intertrochanteric femur nonunion with failed fixation, and the intertan 1.5 11.5mmx38cm 125d lt nail and the lag/comp screw kit 90/85 were found to be fractured.Therefore, they were elected for a revision surgery on (b)(6) 2023, in which the nail was explanted and a synthes competitor device was implanted.Patient was taken to pacu in stable condition, no other complications were reported.

Manufacturer Narrative

Additional information in b7 and h10 (health effect - clinical code & health effect - impact code).

Manufacturer Narrative

A4: weight, b7: other relevant history, including preexisting medical conditions and d11: concomitant medical products and therapy dates h6: health effect - clinical code and health effect - impact code.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveal the intertan nail fracture into two pieces.The clinical/medical investigation concluded that, based on the result of the computed tomography scan on (b)(6) 2023, the clinical cause of the nail breakage, deformity and subsequent revision was the delayed fracture healing with interval increased displacement, in addition to, the presence of poor bone quality noted during the initial device implantation surgery.Moreover, adequate bone blood, supply and vascularization are essential to optimal bone healing and successful implantation outcomes.The impact to the patient was the fall, bone fracture, rhabdomyolysis, the resolved posthemorrhagic anemia, rehabilitation, the explantation of the smith and nephew intertan nail and screw components, pain, and the subsequent revision of the non-union with a competitor¿s device(s).Since all of the smith and nephew components have been removed, no further clinical/medical assessment can be rendered.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A laboratory analysis performed on the device revealed that, it was concluded that the trigen intertan nail fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross section could not bear the imposed patient loading, which led to a fracture.Fatigue cracking is caused by the nail bearing cyclic stresses in excess of the material endurance limit for an extended period.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to excessive patient activity levels prior to full bone union applications of loads in excess of the material¿s strength, or poor bone quality.A review of complaint history for the part number over 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 instructions for use documents for intramedullary nail system revealed in possible adverse effects that cracking or fracture of the implant may occur.Preoperative planning section states that proper type and size of implant must be selected to ensure effective treatment of patients considering factors such as patient¿s size, strength, skeletal characteristics, skeletal health, and general health.Overweight or musculoskeletal deficient or unhealthy patients may create greater loads on implants that may lead to breakage or other failure of the implants.Additionally, postoperative care section warns that early weight bearing substantially increases implant loading and increases the risk of breaking the device.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.According with inspection procedure, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of standard grade titanium, aluminum, and vanadium alloy shall be controlled.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: INTERTAN 1.5 11.5MMX38CM 125D LT
• 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: 18156672
• MDR Text Key: 328356117
• Report Number: 1020279-2023-02250
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556038949
• UDI-Public: 00885556038949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 71676557
• Device Lot Number: 14ET42198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71677090 / LOT# 22DT62583; FEEDING SUPPLEMENTS; HYDROCODONE; LOVENOX
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 74 KG