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

Model Number 72468303

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Positioning Problem (3009)

Patient Problems Failure of Implant (1924); Laceration(s) (1946)

Event Date 01/25/2023

Event Type  Injury  

Event Description

It was reported that, during an internal fixation surgery, a locking screw was inserted by hand into the evos volar plate 3h l wde 48mm in the distal row.The screw did not lock in place and went through the plate.The screw ended up poking through the patient's skin on the other side and was removed that way.It is unknown how the procedure was finished, or if there was any delay.The patient current health status is also unknown.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Based on a review of the limited information provided, the screw did not lock in place, and it went through the plate and poked through the patient¿s skin on the other side and was removed that way.However, the root cause/patient outcome beyond that which has been reported cannot be confirmed nor concluded.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for evos¿ plating system revealed in warnings section that it is extremely important to select the appropriate size and type components.Failure to use the largest possible components or improper positioning may result in loosening, bending, cracking, or fracture of the device or bone or both.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include alignment, size selected, patient anatomy or procedural/user error.Based on this investigation, the need for corrective action is not indicated.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 3H L WDE 48MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16439568
• MDR Text Key: 310189669
• Report Number: 1020279-2023-00410
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556672860
• UDI-Public: 00885556672860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72468303
• Device Catalogue Number: 72468303
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention