MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 2.4MM X 18MM LCK SCR T7 S-T; PLATE, FIXATION, BONE

Catalog Number	74412418
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery, when a vlp ti 2.4mm x 18mm lck scr t7 s-t was inserted into the distal, second line, ulnar side hole of an evos volar plate 4h left std std ti 56mm, the screw and the plate did not lock, since the screw kept rotating.A back-up, same size screw was tried, however the same issue occurred.The surgery was completed, without inserting a screw in the screw hole, and leaving the plate inside the patient.This decision was made, because there was no same size plate available, the issue occurred with only one screw hole, and the others had no problem, and the surgeon thought it would be of higher risk to remove and change all the inserted screws.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned devices does not reveal any defects.A dimensional evaluation revealed defects with the head of the screws.Specifically, the thread form on the head diameter was found to be damaged and malformed.Upon examination, features related to the head (head radius, head form) of the screws were within the specification limits of both the overlay print and the drawing print tolerances.The damaged thread form on the heads could not be verified due to the damage, but all other features were within specification.The parts were also placed in the optical comparator to verify head threads.It was observed that the threads were damaged, likely during the insertion or extraction of the screws.Based on this damage, the unsatisfactory experience could be confirmed.The defects were concluded not to be related to any manufacturing process based on the input from the machinist team.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.The clinical/medical evaluation concluded that the evos volar plate surgical technique indicates the choice of screws, and the order of configuration, is a decision to be made by the individual surgeon.As of the date of the medical investigation, the requested clinical documentation was not provided for review.Therefore, there were no clinical factors identified which would have contributed to the reported event.The patient impact includes the change in surgical technique.No other complications were reported.No further clinical assessment is warranted 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management and information for use files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.According to inspection drawing, which was in place at the production date of the plate, the following inspections occurred on the vlp holes.According with inspection drawing, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.A review of the instructions for use documents for mini-fragment and evos plating system provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.Factors that could contribute to the reported event include size selected or insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: VLP TI 2.4MM X 18MM LCK SCR T7 S-T
• Common Device Name: 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: 18226690
• Report Number: 1020279-2023-02345
• Device Sequence Number: 5531612
• Product Code: HRS
• UDI-Device Identifier: 00885556348741
• UDI-Public: 00885556348741
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74412418
• Device Lot Number: 22AM18270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71158104 / LOT: 21JT54234
• Patient Sex: Unknown