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

Catalog Number 71674068

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/24/2019

Event Type  malfunction  

Event Description

It was reported that threads on drivers sheared when inserting.Backup was available and no delay was recorded.

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 threads on the retaining rod fractured off, rendering the device inoperable.The fractured threads were not returned.Only one device was returned for evaluation.The device was manufactured in 2017 and exhibits signs of significant wear/usage.A review of complaint history did not reveal additional complaints for the listed batch.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 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: SUBTROC LAG SCREW DRIVER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8921833
• MDR Text Key: 155244403
• Report Number: 1020279-2019-03131
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560612
• UDI-Public: 03596010560612
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 10/20/2019

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: 71674068
• Device Lot Number: 12ASP0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 10/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1