MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 42CM 125D LEFT; NAIL, FIXATION, BONE

Model Number	71675517
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation surgery of the hip was performed on (b)(6) 2022, the patient experienced breakage of the device.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a intertan 10s 10mm x 42cm 125d left was explanted and a competitor device was implanted.Patient's current health status is unknown.
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation.However, the photographs were reviewed, and revealed the device broke in two pieces.The clinical/medical investigation stated that the undated, unlabeled image shows the nail is broken at the lag/compression junction, and there also appears a femoral neck fracture but as the image is fluoro, it is not completely clear.In addition to the three undated/unlabeled photos of the explant device, they confirm the nail is broken at the lag/compression junction.However, without a comparison of the immediate post-implantation and the immediate pre-revision x-rays, we are unable to determine the definitive clinical root cause of the reported fracture.Although, we cannot rule out whether the appropriate size nail was selected during the primary procedure, trauma, bone quality or non-compliance with the physician¿s request to offload, as possible contributory factors to the reported failure.The impact to the patient beyond the reported fracture, revision and subsequent post-operative convalescent period cannot be determined.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for intramedullary nail system revealed that early weight bearing substantially increases implant loading and increases the risk of breaking the device.Weight bearing on bones that have failed to heal or healed partially or improperly can cause stress and fatigue in metallic surgical implants with consequent breakage or failure of the implants.This has been identified in postoperative care.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.Verifying the device configuration according to the drawing print is within the steps of the final inspection.Additionally, according to the material specification, the quality and manufacture of standard grade titanium, aluminum and vanadium alloy shall be controlled.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.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 10S 10MM X 42CM 125D 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: 17122196
• Report Number: 1020279-2023-01310
• Device Sequence Number: 12374217
• Product Code: JDS
• UDI-Device Identifier: 00885556344545
• UDI-Public: 00885556344545
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 71675517
• Device Catalogue Number: 71675517
• Device Lot Number: 21AM16311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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: Required Intervention
• Patient Sex: Female