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

Catalog Number 71631066

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/02/2019

Event Type  Injury  

Event Description

It was reported that during surgery, after tightening the screw, the driver was removed without turning/rotating.Then, it was found the tip of the driver was broken.The piece was remained inside the screw head in the body and it was confirmed in x-ray image.No delay.No further information available.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tip of the threads on the retaining rod fractured off the device, rendering it inoperable.The piece that fractured off was not returned.The device was manufactured in 2016 and exhibits signs of extensive wear / usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The medical investigation concluded that this complaint from japan reports the broken tip of a driver was left in a patient.No clinical/medical documentation was provided for this complaint.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.This driver is made of the surgical grade stainless steel and not intended for implantation.The impact to the patient cannot be determined based on the available information.In conclusion, the root cause of the breakage cannot be definitively concluded, however the extensive wear could have been a contributing factor in the issue.The possibility of the retained piece migrating or micro motion could occur.Based on this investigation, the need for corrective action is not indicated.Should 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: 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: 9281443
• MDR Text Key: 165127742
• Report Number: 1020279-2019-03891
• 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: 12/09/2019

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: Health Professional
• Device Catalogue Number: 71631066
• Device Lot Number: 16DM16011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2019
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 10/07/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART NUMBER (B)(4) / LOT NUMBER 04FM09253
• Patient Outcome(s): Hospitalization; Required Intervention