MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM SUP MS CLAV PL 10H L 108MM; PLATE, FIXATION, BONE

Model Number	72469510
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during fixation procedure, the tabs of the evos 3.5mm sup ms clav pl 10h l 108mm did not hold the screw.The plate was implanted and had to be removed, also the screws were removed.Surgeon did a two plate construct with one of their anterior plates, plus a competitors lateral plate.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; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the single undated, unlabeled x-ray image shows the screw head pulled through but the root cause is unknown.According to the report, the surgeon had to remove the implanted plate in addition to, the screws.Two undated, unlabeled photos of the explanted plates were provided which shows the tabs of hole enlarged.It is unknown if the surgical technique was followed as indicated for the screw placement.Therefore, a definitive root cause of the plate fixation issue during surgery could not be concluded.No clinical documentation was provided for review.Based on the information provided, a two-plate construct with one of our anterior plates + a competitor¿s lateral plate was used to complete the procedure and those x-rays were not provided.According to the report, surgeon performed a two-plate construct with one of their anterior plates, with the addition of a competitor¿s lateral plate.All documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.It is unknown if any future impact to the patient with the implantation the combination of competitor¿s implants.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.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 or insertion 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: EVOS 3.5MM SUP MS CLAV PL 10H L 108MM
• 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: 16491553
• Report Number: 1020279-2023-00464
• Device Sequence Number: 6787676
• Product Code: HRS
• UDI-Device Identifier: 00885556726808
• UDI-Public: 00885556726808
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 72469510
• Device Catalogue Number: 72469510
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/03/2023
• 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: Unknown