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Model Number 72200755 |
Device Problem
Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Foreign zipcode (b)(6).
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Event Description
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It was reported that during surgery, when the twinfix titanium 5.0 ultrabraid was being passing, it broke inside the patient.All the pieces were removed with a nipper.The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H6: one 72200755 twinfix ti 5.0 ultrabraid intended for use in treatment has not been returned for evaluation.Due to unavailability, investigation was limited.The information provided states: ¿when the twinfix titanium 5.0 ultrabraid was being passing, it broke inside the patient.All the pieces were removed with a nipper¿.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied.Per instructions for use: ¿excessive force during insertion can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor¿.A review of complaints and manufacturing batch records was preformed, no other complaints of this failure was found.Further investigation is not warranted at this time.
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Search Alerts/Recalls
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