MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 2.4MM X 19MM LCK SCR T7 S-T; PLATE, FIXATION, BONE

Catalog Number	74412419
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an evos wrist procedure, when inserting the vlp ti 2.4mm x 19mm lck scr t7 s-t into the screw hole (the second hole from the most distal ulnar side) of one (1) evos volar plate 4h left std std ti 56mm, the screw and plate did not lock, the screw continued to rotate.The head of the screw appeared to be buried more than other screws.The surgeon tried to remove the screw, but it just rotated and could not be removed.This left the plate and screw in the patient's body.The procedure was resumed, after a non-significant delay.No further information is available at the moment.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the production order 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 was performed, and the mini-fragment plating system reveals in warnings 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.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.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 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: VLP TI 2.4MM X 19MM 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: 18897547
• Report Number: 1020279-2024-00530
• Device Sequence Number: 12697338
• Product Code: HRS
• UDI-Device Identifier: 00885556348796
• UDI-Public: 00885556348796
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: 74412419
• Device Lot Number: 21GM07663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EVOS VOLAR PLATE, LOT#: 22CT60721
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown