MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN NAIL; NAIL, FIXATION, BONE

Model Number 71675384

Device Problem Insufficient Information (3190)

Patient Problems Necrosis (1971); Hip Fracture (2349)

Event Date 03/26/2020

Event Type  Injury  

Event Description

It was reported that the patient has smith+nephew components since 2019.Revision surgery was performed due to pseudarthrosis with accompanying femoral head necrosis on the right hip joint and osteosynthesis femoral neck fracture.Intertan nail was removed.

Manufacturer Narrative

D4 updated.

Manufacturer Narrative

It was reported that a revision surgery was performed due to pseudarthrosis with accompanying femoral head necrosis on the right hip joint and osteosynthesis femoral neck fracture.Intertan nail was removed.The affected complaint device, used in treatment, was returned and evaluated.Visual inspection of the returned product shows scratches and burrs on the part.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of the risk management file and instructions for use documentation revealed this failure mode was previously identified.Some potential probable causes for this event could include but are not limited to trauma injury or patient medical conditions.A clinical analysis noted the operative reports along with an x-ray supports the report of the broken compression screws.The impact to the patient beyond the pain and recovery with 3 surgeries so close together cannot be determined.In conclusion, the provided information does not reveal a root cause for the ¿pseudarthrosis and hip head necrosis¿ nor for the root cause for the ¿luxations¿ post the second revision.However, poor bone quality could have contributed to both issues.Based on this investigation, the need for corrective action is not indicated.Should 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 NAIL
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9968882
• MDR Text Key: 187926445
• Report Number: 1020279-2020-01314
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71675384
• Device Catalogue Number: 71675384
• Device Lot Number: 19CM17872
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71645035/ 19CM07766; 71675040/ 15JM06546
• Patient Outcome(s): Hospitalization; Required Intervention