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

Model Number 71674087

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Event Description

It was reported that, during a trauma surgery while the instruments were inside of the patient, the lag driver retaining rod assay capture stick caught onto a guide pin and seemed to be defective; the piece on the trigen t-handle was broken in the captures of the screwdriver.There were no pieces broken off inside of the patient.The procedure was successfully completed with no significant delay using a smith and nephew back up device.Patient was not harmed.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a trauma surgery while the instruments were inside of the patient, the lag screw driver (b)(4) capture stick caught onto a guide pin and seemed to be defective; the piece on the t-handle (b)(4) was broken in the captures of the screwdriver.There were no pieces broken off inside of the patient.The procedure was successfully completed with no significant delay using a smith and nephew back up device.Patient was not harmed.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned lag screw driver confirmed the inner part that connects to the mating device is damaged on the tip.This device also has extensive wear usage.A review of complaint history on the listed part revealed no additional complaints for the listed batch with the same failure mode a review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of this complaint case revealed there were no patient injuries reported.Per e-mail communication, no pieces broken off inside of the patient and the procedure was completed with a backup device.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.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.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: 11909918
• MDR Text Key: 253533018
• Report Number: 1020279-2021-04873
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010580443
• UDI-Public: 03596010580443
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71674087
• Device Catalogue Number: 71674067
• Device Lot Number: 08LCT0019
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention