MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL NAIL CAP SET SCREW 0MM; OXIMETER, TISSUE SATURATION

Model Number 71656000

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the nail was placed correctly and at the time of securing with the plug, this didn´t fit with the nail.It was decided to leave the patient without a closure cap.No damage to patient occurred.Delay greater than 30 min.

Manufacturer Narrative

The device, intended for use in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.The device was manufactured in 2018.According to clinical/medical investigation , no sufficient documentation was provided to support this event.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.No impact to the patient has been reported.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review for the listed part revealed no prior complaints for the listed failure with same batch number.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: META-NAIL NAIL CAP SET SCREW 0MM
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9395856
• MDR Text Key: 168657378
• Report Number: 1020279-2019-04221
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 03596010585417
• UDI-Public: 03596010585417
• Combination Product (y/n): N
• PMA/PMN Number: K061619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71656000
• Device Catalogue Number: 71656000
• Device Lot Number: 18FM21426
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 80