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

Model Number 71675385

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Hip Fracture (2349)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

Ack3 was not generated and the initial report was not received by fda.Due to the aforementioned, an initial/final report has been submitted the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on a review of the information provided, the root cause of the periprosthetic fracture and subsequent revision was the reported fall.However, it cannot be concluded there was a mal performance of the implant or implant failure of the intertan nail.The patient impact beyond the peri-implant fracture, the reported fall and the subsequent revision could not be determined, as the patient status was unknown.Therefore, no further clinical/medical assessment could be rendered at this time.Should any additional relevant medical information be provided, this case would be re-assessed.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 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 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, 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.(b)(4).

Event Description

It was reported that, after an internal fixation procedure had been performed on the patient's right femur on (b)(6) 2018 to treat an intertrochanteric fracture, the patient sustained a peri-implant fracture and the breakage of the prosthesis as a consequence of a fall twelve (12) weeks postoperatively.A revision surgery was performed on (b)(6) 2018 to treat this issue.The identity of the prosthesis implanted in exchange remains unknown.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.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H6.

• Brand Name: INTERTAN 10S 10MM X 20CM 125D
• Type of Device: 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: 15741085
• MDR Text Key: 303145969
• Report Number: 1020279-2022-04168
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556343647
• UDI-Public: 00885556343647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71675385
• Device Catalogue Number: 71675385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male