MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NAIL CAP 10MM; NAIL, FIXATION, BONE

Model Number 71634010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 07/10/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event 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.

Manufacturer Narrative

H3, h6: 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 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.

• Brand Name: NAIL CAP 10MM
• 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: 15108944
• MDR Text Key: 296653918
• Report Number: 1020279-2022-03491
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010495723
• UDI-Public: 03596010495723
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K981529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Model Number: 71634010
• Device Catalogue Number: 71634010
• Device Lot Number: 07MM02057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2007
• 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): Required Intervention