MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS VOLAR PLATE 3H L STD 48MM; NAIL, FIXATION, BONE

Model Number 72468103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/14/2020

Event Type  Injury  

Event Description

It was reported that during surgery the last 1.8mm locking peg was placed into the styloid process, the peg went through the va hole second from the left in the most distal row.The procedure was completed with the same device.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms based on the limited information the root cause of the peg going through the plate cannot be concluded and cannot rule out not using the drill guide as reported.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.The lot is unknown for this part.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: EVOS VOLAR PLATE 3H L STD 48MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10382600
• MDR Text Key: 202164382
• Report Number: 1020279-2020-03803
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556672808
• UDI-Public: 00885556672808
• 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,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72468103
• Device Catalogue Number: 72468103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention