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

Model Number 71631066

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/03/2020

Event Type  malfunction  

Event Description

It was reported that during a case the screwdriver release handle got twisted at the tip trying to unscrew a retaining rod.Also, the medium hex driver did not want to let go of the head of the screw.The patient was not harmed; the procedure was successfully completed with 5 minutes delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms the tip is twisted and deformed.The device exhibits signs of significant use and wear.This instrument was manufactured in 2008.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.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.

• 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: 10457882
• MDR Text Key: 204505834
• Report Number: 1020279-2020-04239
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010478443
• UDI-Public: 03596010478443
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71631066
• Device Catalogue Number: 71674084
• Device Lot Number: 08FM12924
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1