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

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 01/13/2020

Event Type  Injury  

Event Description

It was reported that patient presented ankle pain.X-rays showed prosthetic fracture.Revision surgery required.

Manufacturer Narrative

It was reported that a patient with evos plate and screws fixation underwent a revision due to a prosthetic fracture.The affected complaint devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.A medical analysis noted that x-rays were provided and reviewed by the medical director and they were noted to have malunion and callous formation, which indicates it was in the process of healing.However, without any supporting medical evidence or the explanted devices, no further medical assessment can be performed at this time.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.Possible causes could include but are not limited to traumatic injury, non-compliant patient or patient bone quality.

• Brand Name: TRAUMA IMPLANT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9703305
• MDR Text Key: 179311013
• Report Number: 1020279-2020-00531
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

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
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention