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	01/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during distal radius fixation, a vlp ti 2.4mm x 18mm lck scr t7 s-t went straight through screw hole on the plate, it wouldn¿t engage in plate and went straight through to bone.Surgery was resumed without any delay with a s+n back-up device.Current health status of the patient is unknown.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection was performed and no damage was able to be detected by naked eye.A dimensional evaluation performed on the device revealed it appears that there is major damage on the head region of the part.There is significant damage on the hex, hex drive, countersink, and head diameter that would not have occurred during the manufacturing process.The damage is likely from the insertion of the screw into the plate using a possibly incorrect hex driver size, causing the driver to slip and damage the part features.When the driver damaged the head, it caused the head to be undersized due to material being missing, possibly causing the locking head not to engage properly.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 revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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.According with inspection drawing, an inspection for part measurements shall be performed in order to verify part dimensions are according to specification.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 surgical technique used or user/procedural variance.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 for future complaints and investigate as necessary.Internal complaint reference number: (b)(4).

• 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: 18552404
• Report Number: 1020279-2024-00192
• Device Sequence Number: 6411798
• Product Code: HRS
• UDI-Device Identifier: 00885556348741
• UDI-Public: 00885556348741
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74412418
• Device Lot Number: 23HM10441
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 01/02/2024; 03/04/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/19/2024; 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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
• Patient Sex: Unknown