MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 18CM 125D; NAIL, FIXATION, BONE

Model Number	71675383
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).
Event or Problem Description
It was reported that, an intertan 10s 10mm x 18cm 125d was implanted on (b)(6) 2023, because of a left pertrochanteric femur fracture caused by a fall.On (b)(6) 2023, during an x-ray control, it was noticed the nail broke, which resulted in fragment dislocation, therefore a revision surgery was performed on (b)(6) 2023, where s+n thr implants were placed.This secondary procedure is not related to a fall.Patients' current health status is unknown.
Additional Manufacturer Narrative
Section h10: the associated device was returned and evaluated.A visual inspection of the intertan nail reveals the nail fracture into two pieces.Both pieces were returned.Also three screws were returned.One of the screws is fractured into three piece revealed by the visual.The other two screws visual reveal normal wear.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 revealed similar events for the listed device over the previous 12 months, but no commonalities that would suggest a device deficiency was found nor an adverse trend, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that an analysis of the post implantation x-ray photos shows undated images, but one does show the shaft break and a persistent femoral neck fracture.However, we are unable to confirm root cause of the reported nail breakage or determine the definitive clinical root cause of the reported events, but an unhealed fracture and the reported fall cannot be ruled out as contributing factors.Although the instructions for use for intramedullary nail system, does warn; ¿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.Additionally, postoperative care section warns that early weight bearing substantially increases implant loading and increases the risk of breaking the device.¿ therefore, it cannot be concluded that the reported events were associated with a malperformance of the implant.Since it was reported the patient¿s health status is unknown, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded with the information provided.Should any additional relevant medical information be provided, this cause 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.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 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.According with material specification, quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.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.Internal complaint reference number: (b)(4).

• Brand Name: INTERTAN 10S 10MM X 18CM 125D
• 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: 17020432
• Report Number: 1020279-2023-01192
• Device Sequence Number: 15298401
• Product Code: JDS
• UDI-Device Identifier: 00885556105696
• UDI-Public: 00885556105696
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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 Model Number: 71675383
• Device Catalogue Number: 71675383
• Device Lot Number: 22KM07193
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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: Required Intervention; Other
• Patient Age: 85 YR
• Patient Sex: Male