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

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

In a scientific publication, sonu mehta et al, 2017, journal of research in medical and dental sciences pissn no.2347-2545, it was reported that a patient presented a fracture displacement at trigen intertan nail insertion/lateral greater trochanteric fracture.Is unknown whether a medical intervention was performed to treat the adverse event.

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 this is a literature study from india ¿ comparing the intertan nail with the proximal femoral nain in proximal femoral fractures by sonu mehta.The results showed better functional results in the intertan group when compared to the proximal femoral nail.For (b)(6), the patient presented with ¿a fracture displacement at nail insertion/lateral greater trochanteric fracture and a medical intervention was required.¿ no individual specific patient medical documentation was provided.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.The patient impact beyonf the additional surgery cannot be determined.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.

• 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: 9532010
• MDR Text Key: 173089091
• Report Number: 1020279-2019-04666
• 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: 04/23/2020

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: 12/10/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention