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

Catalog Number 71751108

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 12/05/2018

Event Type  Injury  

Event Description

It was reported that the humerus surgery, the front end of driver was broken causing the nail to be stuck in the medullary cavity.After the nail was removed, the thread at the front end of the driver was broken in the nail.Then changed another driver and nail.There was a delay greater than 30 minutes.

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 guide bolt fractured off the device and was returned.The driver was not returned for evaluation.The device was manufactured in 2013 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.The clinical investigation concluded that all pieces were removed and a backup driver and nail were used to complete the procedure.Since the 31-60 minute delay did not cause harm to the patient no further clinical/medical assessment is warranted at this time.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.We consider this investigation closed.

• 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: 8206320
• MDR Text Key: 131718162
• Report Number: 1020279-2018-02954
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71751108
• Device Lot Number: 13KDN0235
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other