MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMART FX ID BANDS + CAPS (6+6); APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	71075040
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during treatment with an external fixator, 3 smart fx id bands + caps (6+6), numbers: 6 (violet), 2 (orange) and another (number unknown) fell off the smart fx struts on patient's frame.Also a fourth band (number 1: red) had broken and remained half on/half off.The patient is in equinus frame, non weight bearing.In addition, one smart fx strut long, was missing an id band and had lost it's length.It was assumed that the white button must have been pressed accidentally and engaged the fast fx movement.The patient was not aware of the capabilities of this button.However, the patient could not readjust the strut to it's original position, it had lost about 8mm of length.When trying to lengthen, the strut would slip back and so it was not possible to restore the length.Patient had missed multiple days of adjustments on this strut as a result.Once the new band was replaced onto the strut, it was able to be adjusted once more.Patient current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
D4, h4.Lot number, manufacturing and expiration dates.
Additional Manufacturer Narrative
Results of investigation: the devices were not returned for evaluation.However, the photographs were reviewed, and revealed a broken band (red), half of which still remained in the frame.No evidence of detachment of the other reported bands was observed.A review of the production order for the smart fix id bands and caps did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the smart fix strut long batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the smart fix id bands and caps revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of complaint history for the smart fix strut long for the previous 12 months did not reveal similar events for the listed device.A review of the risk management files 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 products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.These are single use devices, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.Corrected data: h6 (medical device problem code).

• Brand Name: SMART FX ID BANDS + CAPS (6+6)
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 16380144
• Report Number: 1020279-2023-00341
• Device Sequence Number: 5759615
• Product Code: KTT
• UDI-Device Identifier: 00885556746110
• UDI-Public: 885556746110
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2023
• Device Catalogue Number: 71075040
• Device Lot Number: 22BK00240
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 01/19/2023; 04/26/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/15/2023; 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER: 71075730 / LOT: UNKNOWN
• Patient Sex: Unknown