MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T8 LINEAR DRIVER SHAFT W/ AO QC; SCREWDRIVER

Catalog Number 71174986

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2019

Event Type  malfunction  

Event Description

It was reported that the driver was found twisted.Backup device used from competitor company.No more information provided yet.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tip of the driving end is twisted and damaged/ stripped.A review of complaint history for the listed part revealed no prior complaints documentation review not performed for this event, as no manufacturing, packaging or labelling defects were associated with the reported failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: T8 LINEAR DRIVER SHAFT W/ AO QC
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9060672
• MDR Text Key: 158779207
• Report Number: 1020279-2019-03358
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00885556500590
• UDI-Public: 00885556500590
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71174986
• Device Lot Number: 18JUP0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 09/15/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1