MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 1.5MM X 18MM CTX SCR T4 S-T; PLATE, FIXATION, BONE

Model Number	74401518
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, when the vlp ti 1.5mm x 18mm ctx scr t4 s-t was placed, the screw head broke off and the rest of the screw was left inside the bone.The procedure was completed without significant delays.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6.The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no supporting medical documentation has been provided for inclusion in this medical investigation.The provided pilgrim intake form was reviewed; however, it did not aid in confirming the root cause of the reported breakage.According to the report, the headless implantable screw was left screw inside of the patient¿s bone as intended.Therefore, the potential for micro-motion/migration of the retained screw is unlikely.Based on the information provided, the patient was not harmed beyond the reported incident.Should any additional relevant medical information be provided, this case would be re-assessed.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 in warnings section that fracture of the device can occur as a result of failure to use the largest possible components or improper positioning.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.Some potential probable causes for this event could include but not limited to surgical technique, fit/ sizing issue or poor insertion technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 1.5MM X 18MM 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: 15071015
• Report Number: 1020279-2022-03385
• Device Sequence Number: 5516015
• Product Code: HRS
• UDI-Device Identifier: 00885556489741
• UDI-Public: 00885556489741
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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 Model Number: 74401518
• Device Catalogue Number: 74401518
• 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: 07/01/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/25/2022
• 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
• Patient Sex: Female
• Patient Weight: 53 KG