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

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 07/10/2014

Event Type  Injury  

Event Description

In a scientific publication, zhuo chenglong, "comparison between directed anterior approach assisted cannulated screw and intramedullary fixation for young adults with unstable femoral neck fractures" during follow-up, 4 patients in the intertan group presented nonunion of fracture and avascular necrosis of femoral head, it is unknown how these complications were treated.The patients were implanted with an intertan nail but there is no information regarding to the part numbers or sizes involved in the surgeries.

Manufacturer Narrative

The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms a review of the provided journal article provided reported during follow-up, four patients in the intertan group presented with a non-union of fracture and avascular necrosis of femoral head, it is unknown how these complications were treated.Without the requested patient specific clinical information to assist with a clinical investigation a thorough medical investigation cannot be rendered.In addition, the patient's current condition nor the impact to the patient be cannot be determined.No further medical assessment can be rendered at this time.Should any additional medical information be provided this complaint would be re-assessed cannot be performed.Should information become available this complaint can be re-assessed.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• 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: 9633654
• MDR Text Key: 176476421
• Report Number: 1020279-2020-00389
• 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,l
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

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: No Information
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention