MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 40CM 125D LEFT; NAIL, FIXATION, BONE

Model Number	71675515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Implant Pain (4561)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation procedure had been performed on the patient's left femur on (b)(6) 2019 to treat an intertrochanteric fracture, the patient sustained a new periprosthetic stress fracture.Although the specific area in which this fracture developed was not provided, the patient underwent unplanned removal of the hardware on (b)(6) 2019.Additional details regarding the clinical course of the patient were not provided.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf)], additional information is not known, and it is not possible to collect it, we do not have the opportunity to revisit negative feedback to retrieve further information.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, after a left femur internal fixation procedure the patient sustained a new periprosthetic stress fracture and underwent unplanned removal of the hardware approximately 9 months post implantation.As of the date of this medical investigation no relevant supporting clinical information has been provided to assist with this clinical investigation as the data was reported from a retrospective post market clinical follow-up.Therefore, no clinical factors could be assessed which would have contributed to the event.With the limited information provided, the patient impact beyond the reported new periprosthetic stress fracture and subsequent hardware removal cannot be determined.No further medical assessment can be rendered at this time.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed as a care subsequent to bony union that patients should be cautioned against unassisted activity that requires walking or lifting.Postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident.Additional postoperative precautions should be taken when the fracture line occurs within 5 cm of the nail¿s screw hole, as this places greater stress on the nail at the location of the transverse screw hole.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include patient bone quality, post-operative patient condition and/or surgical technique.The contribution of the device to the reported event could not be corroborated.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.
Additional Manufacturer Narrative
Additional information: b5, h6 (health effect - clinical code) h6 (health effect - impact code).
Event or Problem Description
It was reported that, after an internal fixation procedure had been performed on the patient's left femur on (b)(6) 2019 to treat an intertrochanteric fracture, the patient sustained pain in the left knee and a new periprosthetic stress fracture and stress reaction at the distal femur femoral cortex.The patient underwent revision surgery on (b)(6) 2019 to replace the hardware with a new antergrade nail.Additional details regarding the clinical course of the patient were not provided.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, along with the pre-existing left knee degenerative joint disease, the bone scan reportedly confirmed stress reaction there at the anteriorly placed distal tip of intramedullary nail and was suspect for the pain.Additionally, the patient¿s recent fall history and nutritional status cannot be ruled out as potential contributing factors to the reported events.The patient impact is determined to be the reported symptoms and subsequent revision.A transient restorative phase would be anticipated.Documentation 7 weeks post competitor revision indicated the (b)(6) patient was without pain and ambulating/weight-bearing status as tolerated with assist devices with sufficient lower extremity rom and strength.The current patient status is unknown.Device batch number was not provided; thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed as a care subsequent to bony union that patients should be cautioned against unassisted activity that requires walking or lifting.Postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident.Additional postoperative precautions should be taken when the fracture line occurs within 5 cm of the nail's screw hole, as this places greater stress on the nail at the location of the transverse screw hole.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 40CM 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 vigilance@smith-nephew.co ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15459778
• Report Number: 1020279-2022-04124
• Device Sequence Number: 20226154
• Product Code: JDS
• UDI-Device Identifier: 00885556344446
• UDI-Public: 00885556344446
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71675515
• Device Catalogue Number: 71675515
• 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: 08/31/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 08/12/2024; 09/27/2024
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/20/2022; 08/13/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White