MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 40CM 130D LEFT; NAIL, FIXATION, BONE

Catalog Number	71675516
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation procedure had been performed on (b)(6) 2024, the patient experienced a broken intertan 10s 10mm x 40cm 130d left after fracture not healing.A revision surgery was performed on (b)(6) 2024 to address this adverse event.In addition to the nail, one (1) lag/comp screw kit 95/90 was also explanted.Surgeons confirmed that it is biology (non-union) was the reason for nail failure.Revision operation went well as can be expected.Patient expected to heal and recover well.
Additional Manufacturer Narrative
Internal reference number: case (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated devices were returned and evaluated.The visual inspection revealed that the intertan nail fractured into two pieces.Both pieces were returned.The screws were returned as well and the visual reveals signs of wear.This inspection was conducted by naked eye.The clinical/medical investigation concluded that the provided photos and x-rays were reviewed and confirm the fracture and broken intertan.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.There is a definitive clinical route cause.The surgeons confirmed that it is biology (nonunion) was reason for nail failure and subsequent revision.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The im nail fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross-sectional area of the nail could not bear the imposed patient loading, which led to an overload fracture.Fatigue cracking was likely caused by the nail bearing cyclic stresses more than the material endurance limit for an extended period of time.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, and/or poor bone quality.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.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.Early weight bearing should only be considered where there are stable fractures with good bone-to-bone contact.Patients who are obese and/or noncompliant, as well as patients who could be pre-disposed to delayed or non-union, should have auxiliary support.Patients and nursing care providers should be advertised of these risks.A review of the risk management files 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 these products and event.According with the inspection procedures, the visual inspection includes the verification of part configuration per print.Also, per material specifications, the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.At this time, we have no evidence to conclude that the products 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 10S 10MM X 40CM 130D LEFT
• 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: 19893013
• Report Number: 1020279-2024-01492
• Device Sequence Number: 12707218
• Product Code: JDS
• UDI-Device Identifier: 00885556344491
• UDI-Public: 00885556344491
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2024

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
• Device Catalogue Number: 71675516
• Device Lot Number: 20HM06790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown