MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NAIL CAP 0MM; NAIL, FIXATION, BONE

Model Number 71634000

Device Problem Connection Problem (2900)

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

Event Date 10/11/2020

Event Type  Injury  

Event Description

It was reported that during procedure when the tibial intramedullary nail was finally put on the nail cap, there was a problem with the thread of the nail cap, which could not be screwed in.Surgery was completed with an s+n backup device.No information about injuries or surgical delays were reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms the stated failure.The threads are damaged on the nail cap.The device was manufactured in 2019.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible probable cause could include but not limited the user error.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: NAIL CAP 0MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10825980
• MDR Text Key: 215883550
• Report Number: 1020279-2020-06394
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010495709
• UDI-Public: 03596010495709
• Combination Product (y/n): N
• PMA/PMN Number: K981529
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71634000
• Device Catalogue Number: 71634000
• Device Lot Number: 19FM18207
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1