MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5 MM 1/3 TUBULAR PL 7H 82MM; PLATE, FIXATION, BONE

Catalog Number	72440807
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation surgery had been performed on (b)(6) 2023, the evos 3.5 mm 1/3 tubular pl 7h 82mm broke into two pieces.This adverse event was treated by a revision surgery on (b)(6) 2023 in which the device was explanted.Current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited information provided, the clinical root cause of the reported internal fixation device breakage cannot definitively concluded but the persistent fracture of the fibula is noted.The patients weight bearing status and compliance could also be a factor as the fracture was not healed.The provided x-ray confirms the stated device failure of evos plate breakage and persistent bone fracture.The impact to the patient is the revision and prolonged rehabilitation.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 vos¿ plating system revealed in warnings section 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.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 inspection procedure, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of stainless steel for surgical implants 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, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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.H11 ¿ corrected data.D8- device available for evaluation.
Additional Manufacturer Narrative
H3, h6: the device was received for evaluation at the manufacturing site, but a physical product evaluation was not possible.The clinical/medical investigation concluded that, based on the limited information provided, the clinical root cause of the reported internal fixation device breakage cannot definitively concluded but the persistent fracture of the fibula is noted.The patients weight bearing status and compliance could also be a factor as the fracture was not healed.The provided x-ray confirms the stated device failure of evos plate breakage and persistent bone fracture.The impact to the patient is the revision and prolonged rehabilitation.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 evos¿ plating system revealed in warnings section 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.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 inspection procedure, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of stainless steel for surgical implants shall be controlled.At this time, we have no evidence to conclude 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, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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: EVOS 3.5 MM 1/3 TUBULAR PL 7H 82MM
• 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: 18314844
• Report Number: 1020279-2023-02491
• Device Sequence Number: 6152039
• Product Code: HRS
• UDI-Device Identifier: 00885556646960
• UDI-Public: 00885556646960
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2024

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: 72440807
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 05/02/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/10/2024; 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 56 YR
• Patient Sex: Female
• Patient Weight: 66 KG