MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS DRAD DORS PL 3H L TI WIDE 58MM SAMP; PLATE, FIXATION, BONE

Catalog Number 71195170

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2020

Event Type  malfunction  

Event Description

It was reported that, whilst the label and actual part references to 71195170, the actual product is 71195169 instead of 71195170.As this was noticed upon inspection, no case was involved.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, was not returned for evaluation ,but per the attached pictures, the reported event could be confirmed.This issue was previously identified and evaluated through our internal quality hold process.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing or product specifications for batch did not reveal abnormalities that could have contributed to the reported issue.The potential probable cause for this event is a manufacturing process error.Based on this investigation, the need for corrective action is indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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.We consider this investigation closed.

• Brand Name: EVOS DRAD DORS PL 3H L TI WIDE 58MM SAMP
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10766876
• MDR Text Key: 214091247
• Report Number: 1020279-2020-05970
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556728932
• UDI-Public: 885556728932
• Combination Product (y/n): N
• PMA/PMN Number: K140814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71195170
• Device Lot Number: 20CT35339
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1