MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS VOLAR PLATE 4H L WDE 56MM; PLATE, FIXATION, BONE

Model Number 72468304

Device Problem Fitting Problem (2183)

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

Event Date 07/21/2020

Event Type  Injury  

Event Description

It was reported that during an open reduction internal fixation (orif) of left distal radius the radial styloid locking peg in the most distal row of the plate was place successfully.A second screw hole was made proximal to this and an attempt was made to insert a locking peg at which point the surgeon claimed to encounter difficulty in being able to engage the threaded head of the peg with the petals in the plate.Several attempts were made before the surgeon decided to leave the hole empty.During surgery the drill block guide was not used.Another plate was taken from the set and the surgeon tried to insert a locking peg into the distal row of the plate at which time he was able to drive the peg completely through the plate.However this was on the third attempt and with some force.The surgeon then went on to try different holes within the plate using different pegs with the same result after more than one attempt to lock, unlock and then drive the peg through the plate hole.The plate being returned shows that in each of the distal holes the petals have been deformed/destroyed in the process.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this complaint from the united kingdom reports trouble inserting the pegs into the holes in the plate during an open reduction internal fixation (orif) of left distal radius procedure.Another plate was taken from the set and the surgeon tried to insert a locking peg into the distal row of the plate at which time he was able to drive the peg completely through the plate.This was on the third attempt and with some force used.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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 VOLAR PLATE 4H L WDE 56MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10408955
• MDR Text Key: 202979142
• Report Number: 1020279-2020-03931
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556672877
• UDI-Public: 00885556672877
• Combination Product (y/n): N
• PMA/PMN Number: K181533
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72468304
• Device Catalogue Number: 72468304
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention