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

Model Number 71158103

Device Problems Flaked (1246); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  Injury  

Event Description

It was reported that, during an im nail procedure, while tightening the screw in the uevos volar plate 3h left std ti 48mm, the holes of the plate got damaged and the entire screw passed through the plate along with some fragments of metal.The surgery couldn't be completed.The patient's current health status is unknown.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

H10: additional information received in b5 and h6 (health effect - impact code was updated).

Event Description

It was reported that, during an im nail procedure, while tightening the screw in the evos volar plate 3h left std ti 48mm, the holes of the plate got damaged and the entire screw passed through the plate along with some fragments of metal.No pieces entered to patient.Surgery was completed, with a less than or equal to 30 minutes delay, with a competitor device.The patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation but the pictures were reviewed, and the damage of the holes was confirmed.The clinical/medical investigation concluded that, this case reports that the holes of the evos plate got damaged and the entire screw passed through the plate along with some fragments of metal; however, ¿no pieces entered to patient¿.Reportedly, the surgery was completed with a competitor device with a less than/= 30 minute delay.The provided photocopied images of the plate were reviewed and appear to support the complaint; however, the photos do not provide insight into the root cause of the reported event.Based on the limited information provided, the root cause of the reported event could not be definitively concluded.The device surgical technique does note: ¿it is not recommended to engage the variable-angle locking mechanism more than 2 times during screw insertion.Also, repeated use or damage to variable-angle locking tabs can cause screws to not lock to plate and screws to pass through plate¿.No patient injuries or adverse consequences were reported.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for evos¿ plating system revealed 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 has been identified as a warning.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 product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used or user/procedural variance.The contribution of the device to the reported event could be corroborated since it wasn't used in the procedure because it was damaged.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 LEFT STD TI 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: 14808855
• MDR Text Key: 294871671
• Report Number: 1020279-2022-03101
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556693780
• UDI-Public: 00885556693780
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K181533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71158103
• Device Catalogue Number: 71158103
• Device Lot Number: 20GT39223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2020
• 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