MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 1.5MM X 8MM CTX SCR T4 S-T; PLATE, FIXATION, BONE

Catalog Number	74401508
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a metacarpal osteosynthesis surgery, when a vlp ti 1.5mm x 8mm ctx scr t4 s-t was being placed, it broke off, leaving the body inside the patient and the head outside.An attempt was made to remove it but due to its size it was not possible and was left inside of the patient.The procedure was resumed, after a non-significant delay, with a backup s+n device.No further complications were recorded as a result of this situation.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation.However, the photograph was reviewed, and revealed that the screw is fractured.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 definitively contributed to the event.Per case details, during a metacarpal osteosynthesis surgery, the mini system screw broke when passing the cortical screw and split leaving the body inside the patient and head outside.Reportedly, an attempt to remove the device was unsuccessful and the device was ¿left inside the patient.¿ the provided photo was reviewed and appears to show a broken piece of the device, however, does not aid in determining the root cause of the reported device breakage.The patient impact beyond the reported screw breakage cannot be determined.The potential for micro-motion and/or migration, and local skin irritation/discomfort cannot be rule out if any portion of the device is left unsecured.Per case communication, the procedure was completed with a non-significant delay using a smith and nephew backup device.It was further reported, ¿the patient¿s health was not affected.¿ 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 mini-fragment plating system revealed that cracking or fracture of implant components has been identified as adverse effects.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 the material specification, the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.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 size selected, surgical technique or excessive forces.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.We consider this investigation closed.

• Brand Name: VLP TI 1.5MM X 8MM CTX SCR T4 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: 17604626
• Report Number: 1020279-2023-01645
• Device Sequence Number: 6161823
• Product Code: HRS
• UDI-Device Identifier: 00885556489246
• UDI-Public: 00885556489246
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K143050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/20/2023

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: 74401508
• Device Lot Number: UNKNOWN
• 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: 08/05/2023
• Supplement Date Received by Manufacturer: 08/05/2023; 09/19/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/04/2023; 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 45 KG