MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG SCREW DRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71674067

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation. a visual inspection confirms the threads appear to be stripped on device.This device also has significant signs of wear/usage.The manufacturing date for this device is 2015.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

Event Description

It was initially reported that the threads of a lag screw driver were seen to be damaged.As noticed upon inspection, no case was involved.The results of the investigation conducted by the manufacturer show that the threads appear to be stripped on the lag screw driver.This is a reportable malfunction pursuant to 21 c.F.R.814.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the threads appear to be stripped on device.This device also has significant signs of wear/usage.The manufacturing date for this device is 2015.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LAG SCREW DRIVER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10378519
• MDR Text Key: 202014827
• Report Number: 1020279-2020-03766
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560605
• UDI-Public: 3596010560605
• 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
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71674067
• Device Lot Number: 15FSP0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1