MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA IMPLANT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71677100

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 12/01/2019

Event Type  Injury  

Event Description

It was reported a revision surgery was performed due to the breakage of the components in the system.First, the fracture of the inferior screw was detected.And later a complete implant failure occurred (breakage of the nail).

Manufacturer Narrative

It was reported a revision surgery was performed due to the breakage of the inferior screw and nail.The affected intertan nail and the screws, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A medical analysis noted the x-rays provided confirm the breakage and femoral neck non-union.The impact to the patient beyond the revision cannot be concluded.No further clinical assessment is warranted at this time.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but are not limited to healing complications that weakened bone, impeded fixation, or otherwise led to premature fracture of implant.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TRAUMA IMPLANT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9537096
• MDR Text Key: 173279160
• Report Number: 1020279-2019-04804
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71677100
• Device Lot Number: 19DT19756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART NO.: 71645035 / LOT NO.: 18HM05676; PART NO.: 71645040 / LOT NO.: 19EM14777
• Patient Outcome(s): Hospitalization; Required Intervention