DEPUY MITEK LLC US BARREL TORNADO BURR 5.5MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
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Model Number 283889 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 11/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Udi: (b)(4).The lot number is not currently available.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported by affiliate in (b)(6) that during a rotator cuff repair surgical procedure, it was observed that a metal debris from 5.0 mm barrel tornado burr plus device was released into the joint.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the event had no impact on the procedure as the little fragments had been aspirated.It was reported that the procedure had not been stopped; therefore, there was no delay on the procedure.It was reported that there was no need of an alternative product.D4: the lot number was reported as unknown on the initial report and has been updated as m1906039.Therefore, udi: (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = > the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [m1906039] number, and no non-conformances were 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.Udi: (b)(4).
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