MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STRAIGHT NAIL GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71751108

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2019

Event Type  malfunction  

Event Description

It was reported that during surgery guide bolt is stripped.No harm to patient or staff.5 minute procedural delays.Smith & nephew back-up was not available.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The threads on both ends of the device are damaged, rendering them inoperable.The hex end is also heavily damaged from impacts.The device was manufactured in 2004 and exhibits signs of extensive wear/usage.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 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.

• Brand Name: STRAIGHT NAIL GUIDE BOLT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8958231
• MDR Text Key: 156391291
• Report Number: 1020279-2019-03260
• Device Sequence Number: 1
• Product Code: HSB
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71751108
• Device Lot Number: 472419A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1