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Model Number 212865 |
Device Problems
Break (1069); Positioning Failure (1158)
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Patient Problem
Not Applicable (3189)
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Event Date 09/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Udi:(b)(4) )incomplete.The lot number is unknown at this time.
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Event Description
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It was reported via complaint submission tool that during a hand surgery two micro quickanchor plus preloaded with 3/0 ethibond suture and v-4 needles failed, first anchor plastic sheeth around anchor broke, second anchor did not release from inserter.There was cartilage injury from first anchor with broken plastic sheet.No surgical delay was reported.Additional information received from the affiliate reported the exact trigger mechanism is unknown.It was also reported that a surgical delay of a few minutes occurred and a cartilage injury from anchor no 1 with broken plastic inserter sheeth.It was reported the case was completed with an alternative pds suture and separate single use needle.The devices were discarded and will not be retuned for evaluation.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.A manufacturing record evaluation was performed for the finished device lot number (6l77834), and no non-conformance was identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D4, h4: the lot number, expiration date, udi and manufacture date were all reported as unknown on the initial report.Al fields have been updated accordingly.Udi: (b)(4).
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Search Alerts/Recalls
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