MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HUMERAL NAIL 8/7MM X 26CM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71770826

Device Problem Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2020

Event Type  Injury  

Event Description

It was reported that during surgery, while removing the guide rod, the ball part on the guide rod stuck at the distal end of the nail after inserting the nail.So, the guide rod couldn't be removed.Then, the inserted nail and the stuck guide rod were removed together from bone.It was tried to separate the rod and nail outside body, but it did not succeed.Finally, using back-up guide rod and smaller size nail (24cm), the procedure was completed.40 minutes delay.No remain inside body.Devices will be returned for evaluation.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A guide wire is stuck inside the nail and cannot be removed, rendering the device inoperable.The device was manufactured in 2017.The clinical medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.Per communications, the reported surgical delay in the procedure did not result in any patient harm to the patient, no objects where retained in the patient, and the procedure completed using backup devices.Since no future harm is anticipated to this patient no further clinical/medical investigation is warranted at this time.Should any additional medical information be provided, this complaint will be re-assessed.A dimensional inspection was attempted, but the inner diameter could not be evaluated as the guide rod obstructed the cannulation and could not be removed.There is no evidence to suggest that the nail was manufactured incorrectly.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a fit / sizing issue or poor surgical technique.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: HUMERAL NAIL 8/7MM X 26CM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10069859
• MDR Text Key: 191399679
• Report Number: 1020279-2020-01781
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K032722
• 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: 02/05/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71770826
• Device Lot Number: 17DSM0391
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention