MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN COMPRESSION SCREW; SCREW, FIXATION, INTRAOSSEOUS

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that a revision surgery will be scheduled due to the intertan compression screw backing out.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, without the requested clinical information, revision report or the explant, the root cause of the compression screw backing out cannot be concluded.Since we currently do not have a record of the proposed revision, the future impact to the patient due to the compression screw backing out cannot be determined.No further clinical/medical assessment is warranted at this time.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: INTERTAN COMPRESSION 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: 7604395
• MDR Text Key: 111145349
• Report Number: 1020279-2018-01119
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 05/17/2018
• 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