MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 11.5 X 38 130 D TAN RT ROSE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71648338
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349)
Date of Event	07/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery was performed on 2008, the patient suffered a periprosthetic fracture after a fall.This adverse event was solved by a revision surgery on (b)(6) 2022, where the 11.5 x 38 130 d tan rt rose, the nail cap 10mm and two (2) unknown trigen tan/fan nail screw were explanted.Current health status of patient is unknown.
Additional Manufacturer Narrative
Additional information added: d4 (expiration date), h4, h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation but the pictures were provided and according to the clinical/medical evaluation the undated/unidentified x-ray photocopy image shows a fracture of the femur in the area of the femoral neck.Based on the information provided, the root cause of the periprosthetic fracture and subsequent revision was the reported fall.The patient impact beyond the reported fall, fracture, and revision procedure could not be determined, as the patient status was unknown.No further 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 the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed that intramedullary nails are not substitutes for skeletal healing, and proper follow-up care is essential to safe and effective use has been identified as a 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and traumatic injury.The contribution of the device to the reported event could not be corroborated, since we cannot confirm that the device caused the periprosthetic fracture.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.Corrected data: h6(health effect - clinical code & health effect - impact code).

• Brand Name: 11.5 X 38 130 D TAN RT ROSE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 15108934
• Report Number: 1020279-2022-03490
• Device Sequence Number: 4190918
• Product Code: HSB
• UDI-Device Identifier: 03596010501264
• UDI-Public: 03596010501264
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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 Expiration Date: 09/27/2016
• Device Model Number: 71648338
• Device Catalogue Number: 71648338
• Device Lot Number: 06JM15539
• 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: 07/10/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2006
• 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: Unknown