MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MEDIUM HEXDRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71631066

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2018

Event Type  malfunction  

Event Description

It was reported that a malfunction occured during operation, when the driver was connected to a proximal screw and rotated, the connection was not tight but loose.Surgeon had to divert from the original procedure using sureshot driver to continue the operation.There was no delay and no patient harm due to this issue.

Manufacturer Narrative

The medium hex driver was returned and evaluated.A visual inspection found that the hex end of the driver had deformation from use.The threads on the driver shaft were worn and would not allow the corresponding screw to properly seat; this was confirmed with a function check.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.No additional complaints were found during the complaint history review.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: MEDIUM HEXDRIVER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8028827
• MDR Text Key: 125819616
• Report Number: 1020279-2018-02329
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71631066
• Device Lot Number: 08AM09167
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1