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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 11/07/2019

Event Type  Injury  

Event Description

It was reported that after surgery, in both cases, the intertan compression-screws migrated from their implantation position.No injury reported.

Manufacturer Narrative

Information update: b5.

Event Description

It was reported that after surgery, the intertan compression-screw migrated from its implantation position.A medical intervention was performed to solve the malfunction.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, without supporting documentation and product information/return/evaluation, the component could not be verified.The definitive root cause of and the patient impact beyond the possible intra-op femoral fracture, screw migration and the subsequent medical intervention could not be concluded by the images alone.The surgical technique does provide sizing, drilling and locking techniques to achieve a proximal locking construct.No further medical assessment could be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include abnormal loading or traumatic event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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.

• Brand Name: TRAUMA-DUMMY IMPLANT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9396084
• MDR Text Key: 168646952
• Report Number: 1020279-2019-04226
• 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,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention