MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WIRE TENSIONER; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 71070341

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 09/09/2020

Event Type  malfunction  

Event Description

It was reported from the loaners department that the instrument does not retains tension.It is unknown when the event occurred.No patient harm reported.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device does not confirm any obvious damage to the device.The device was manufactured in 2013.The device exhibits signs of normal wear and use.A functional testing of the returned device confirms that the device would not rotate and will get seized up while tensioning the wire.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 a manufacturing abnormality that could have caused or contributed to the reported incident.This device exhibits signs of extensive wear/usage.This device is a reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: WIRE TENSIONER
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10637183
• MDR Text Key: 210149332
• Report Number: 1020279-2020-05175
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 08033201842072
• UDI-Public: 08033201842072
• Combination Product (y/n): N
• PMA/PMN Number: K093047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71070341
• Device Catalogue Number: 71070341
• Device Lot Number: 10MP01923
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1