MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 7/16 GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71674071

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Event Description

It was reported that during surgery the guide bolt wrench head snapped off inside the guide bolt.All pieces accounted for.Delay of over 2 hours reported.No injury reported.Procedure finished with competitor device.

Manufacturer Narrative

The associated guide bolt and guide bolt wrench were returned and evaluated.A visual inspection found that the hex head of the wrench has sheared off; the broken piece was returned with the device.The hex feature can break if the torque applied to the driver exceeds the material strength.The device was manufactured in 2007.The guide bolt was stuck inside the drill guide and could not be removed.The date of manufacture is unknown for this part.Our investigation did not determine a specific cause of the stated failure.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: 7/16 GUIDE BOLT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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 ; 0148276373
• MDR Report Key: 8104357
• MDR Text Key: 128389112
• Report Number: 1020279-2018-02595
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560643
• UDI-Public: 03596010560643
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71674071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1