MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.0MM X 12MM LCK SCR T6 S-T; PLATE, FIXATION, BONE

Model Number	72412012N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that after a wrist surgery performed on (b)(6) 2022 one of the evos 2.0mm x 12mm lck scr t6 s-t broke with just hand twisting.A revision surgery was performed on (b)(6) 2022 to solve the issue.Further information is unknown at the moment.
Event or Problem Description
It was reported that after a road traffic accident, the patient had a plating surgery on the 2nd metacarpal bone on (b)(6) 2022.During surgery, while the surgeon was inserting the evos 2.0mm x 12mm lck scr t6 s-t with finger twisting force, it fractured.However the device was embedded and was unable to explant.After the surgery the patient presented an infection that was addressed via revision surgery on (b)(6) 2022 and the evos 2.0mm x 12mm lck scr t6 s-t was explanted.The patient current status is unknown.
Additional Manufacturer Narrative
D4, h3, h6: the device was not returned for evaluation but the pictures were reviewed, and the fracture was confirmed.The clinical/medical investigation concluded that, based on the information, the device remains implanted.Therefore, we cannot confirm the root cause of the reported fracture.Although, excessive force cannot be ruled out as a possibility as it was reported the surgeon inserted it with ¿finger twisting force.¿ the ifu for the evos plating system warns: ¿intra-operative fracture or breaking of instruments can occur.Instruments which have experienced extensive use or excessive force are susceptible to fracture.¿ in additional it was reported there was an infection which cannot be confirmed as related to the broken screw which is an implantable product.According to the report, the patient was revised to treat this adverse event and the broken screw was removed.Since, it was reported the patient¿s outcome is unknown, the impact to the patient beyond that which has been reported, cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Verifying the device configuration according to the drawing print is within the steps of the final inspection, additionally, as part of the material specifications, the quality and manufacture of special stainless steel should be controlled.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for mini-fragment plating system revealed that it is extremely important to select the appropriate size and type components.Failure to use the largest possible components or improper positioning may result in loosening, bending, cracking, or fracture of the device or bone or both has been identified as a warning.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.A review of the sterilization records revealed the batch was sterilized within normal parameters.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 excessive forces applied to implant, surgical technique, contamination, patient reaction, and post-operative healing issue.The contribution of the device to the reported incident could be corroborated as the x-rays confirm the fracture screw.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.B5: describe event or problem.

• Brand Name: EVOS 2.0MM X 12MM LCK SCR T6 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: 14843049
• Report Number: 1020279-2022-03136
• Device Sequence Number: 4744480
• Product Code: HRS
• UDI-Device Identifier: 00885556443644
• UDI-Public: 00885556443644
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K140814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 09/20/2022

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: 72412012N
• Device Catalogue Number: 72412012N
• Device Lot Number: 21DM11079
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 09/20/2022
• Date Device Manufactured: 04/16/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 85 KG