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Model Number 71070705 |
Device Problems
Material Fragmentation (1261); Device Markings/Labelling Problem (2911); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2021 |
Event Type
malfunction
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Event Description
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It was reported that (3) fast fx strut for tsf {} med (case: (b)(4), case: (b)(4), case: (b)(4)), (6) fast fx strut x-short (case: (b)(4), case: (b)(4), case: (b)(4), case: (b)(4), case: (b)(4), case: 2021(b)(4)), (6) fast fx strut for tsf {} sht (case: (b)(4), case: (b)(4), case: (b)(4), case: (b)(4), case: (b)(4), case: (b)(4)) and (1) fast fx strut for tsf {} lng (case: (b)(4)) are loosing the black coating on the outside making impossible to read the numbers.Some also will not allow the shoulder bolts to thread in.It is unknown whether the event happened and if there was a patient involvement.
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Manufacturer Narrative
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H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is severely scratched up and missing the coating, making it difficult to read the ruler.This renders the device inoperative.The device is able to thread bolts in.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Wear potential causes could include but are not limited to friction, joint tightness or lifetime of device.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 future complaints and investigate as necessary.We consider this investigation closed.
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Search Alerts/Recalls
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