MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREWDRIVER RELEASE HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71674084

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 04/05/2021

Event Type  malfunction  

Event Description

It was reported that during set up for an internal fixation, it was noticed that the tip of a screwdriver release handle was bent.No patient injury was reported.There was no significant delay and the procedure was finished by changing the surgical technique.

Manufacturer Narrative

G3, h1,h3, h6: the associated device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned screwdriver release handle is bent at the tip of the device.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.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.D9: sample returned.

• Brand Name: SCREWDRIVER RELEASE HANDLE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11729589
• MDR Text Key: 247552168
• Report Number: 1020279-2021-03487
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560810
• UDI-Public: 03596010560810
• 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
• Report Date: 07/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71674084
• Device Catalogue Number: 71674084
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1