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

Model Number	74401508
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during metacarpal osteosynthesis, at the time of placing the 6-hole straight plate, the first screw was placed, the vlp ti 1.5mm x 8mm ctx scr t4 s-t passed and the head of the screw broke when it was being screwed.The body of the screw remained inside the patient and it could not be removed.No significant delays were reported and the health condition of the patient is stable.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the broken device was confirmed.The clinical/medical investigation concluded that, one undated photo of the broken screw head was provided for review and confirms the reported.Without the requested clinical information such as the post-operative notes and x-ray images, the reported screw breakage could not be further assessed.The vlp ti screw is implantable, biocompatibility is not an issue.There is potential risk for corrosion and local irritation, migration, tissue inflammation, and/or pain.No further clinical/medical assessment is warranted at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 procedural variance or surgical 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 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
• MDR Report Key: 11817079
• Report Number: 1020279-2021-04176
• Device Sequence Number: 11699027
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 74401508
• Device Catalogue Number: 74401508
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Weight: 70