MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 20CM 125D; NAIL, FIXATION, BONE

Model Number	71675385
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/18/2020
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 right femur on (b)(6) 2020 to treat an unspecified hip fracture, the patient sustained a ground level fall with a periprosthetic midshaft femoral fracture at the tip of the nail.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.Any additional details regarding this intervention were not provided, and the patient's outcome remains also unknown.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, a revision was performed approximately 2 months post implantation due to patient sustained a ground-level fall with a periprosthetic midshaft femoral fracture at the tip of the nail.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.Reportedly, further information is not available, and the device is not available for return.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 revision for the periprosthetic fracture following a fall cannot be determined.No further medical assessment can be rendered at this time.A review of complaint history of the previous 12 months revealed similar events for the listed device, 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 the 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, this has been identified as a post operative 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.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 and traumatic injury.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.

• Brand Name: INTERTAN 10S 10MM X 20CM 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: 15459910
• Report Number: 1020279-2022-04127
• Device Sequence Number: 4468315
• Product Code: JDS
• UDI-Device Identifier: 00885556343647
• UDI-Public: 00885556343647
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 71675385
• Device Catalogue Number: 71675385
• 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
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/20/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White