MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 2.0MM X 9MM CTX SCR T6 S-T NS; PLATE, FIXATION, BONE

Model Number	74402009N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during osteosynthesis procedure performed in the metacarpal with a 2.0 straight plate through 6 holes, the bone was drilled and measured to use a vlp ti 2.0mm x 9mm ctx scr t6 s-t ns.At the moment of placing the screw, the head was removed, leaving the body inside the patient.The procedure was completed with a less than or equal to 30 mins delay using the same device.No other complications were reported.Patient's health condition is stable.
Additional Manufacturer Narrative
G3, h2,h3 and h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was fractured along the threads, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical evaluation concluded that no clinically relevant supporting documentation was provided for review.Based on the limited information provided the root cause of the screw breakage could not be determined.It is unclear if the ifu were adhered to; however, it does caution that ¿excessive force should not be placed on the delivery instrument.The starter must be utilized with the screws to minimize screw breakage during insertion.¿ the broken screw is made of a bio-composite material which is intended for implantation to allow for bone ingrowth.Per report, the head broke and was removed, and the body of the screw was left inside of the patient.The body of the screw is in the bone; therefore, micro-motion and migration is unlikely.Based on the information provided, the procedure was completed with a less than or equal to 30 mins delay using the same device.Since no other complications were reported and the patient's health condition is stable; no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.A potential probable cause could be but is not limited to using excessive torque (by hand or power) to seat the screw.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 2.0MM X 9MM CTX SCR T6 S-T NS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11648458
• Report Number: 1020279-2021-02922
• Device Sequence Number: 19672125
• Product Code: HRS
• UDI-Device Identifier: 00885556382349
• UDI-Public: 00885556382349
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 74402009N
• Device Catalogue Number: 74402009N
• Device Lot Number: 18AM17829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 08/09/2021
• 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