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

Model Number	72468103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10382600
• Report Number: 1020279-2020-03803
• Device Sequence Number: 3551939
• Product Code: JDS
• UDI-Device Identifier: 00885556672808
• UDI-Public: 00885556672808
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 72468103
• Device Catalogue Number: 72468103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 01/14/2021; 06/19/2021
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 02/02/2021; 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention