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Catalog Number 222130 |
Device Problem
Material Frayed (1262)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The exp date is currently unavailable.The complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy 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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
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Event Description
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It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the strands of fastin 3.0mm #2 eth *ea suture device snapped.According to the reporter, the event occurred when tensioning for the first know when it was inserted into the patient's anchor by hand.It was reported that the event occurred once the surgeon was satisfied with the depth of the anchor and began to tie the strands into knot.It was reported that the surgeon was able to complete the repair using loose sutures.It was reported that the suture broke above the anchor joint and not the joint interface.It was reported that after the breakage, the anchor was left in the patient to prevent any further damage to the bone and no other implants were used just a stay suture to complete the repair.It was not reported if there was a delay in the surgical procedure or if a spare device was used to complete the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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Product complaint #: (b)(4).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.
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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.Udi: (b)(4).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.This supplementary medwatch is being filed to capture complete udi no other changes are required.
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Search Alerts/Recalls
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