MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLOCKED VLP SCREW; SCREW, FIXATION, INTRAOSSEOUS

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 06/04/2018

Event Type  Injury  

Event Description

It was reported that during a surgical intervention a part of the blocked screw remained in the patient.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.However according to the detail page the revision surgery was performed due to periprosthetic fracture after patient fall.No further clinical/medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: BLOCKED VLP SCREW
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7634316
• MDR Text Key: 112193488
• Report Number: 1020279-2018-01195
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR