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 10/21/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the screwdriver tines were twisted at the end.The procedure was completed using a competitor backup device.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection confirms the device has a damaged tip.The device shows significant signs of wear/usage.The manufacturing date for the device is 2017.A complaint history and dhr review was not performed for this event, as no manufacturing, packaging or labelling defects were associated with the reported failure.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9353869
• MDR Text Key: 167352372
• Report Number: 1020279-2019-04116
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00885556500590
• UDI-Public: 00885556500590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2019

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: 17HUP0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1