DEPUY MITEK MICROFIX QUICKANCHOR PLUS, 3/0 SUTURE; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
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Catalog Number 212843 |
Device Problems
Loss of or Failure to Bond (1068); Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/30/2014 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: this complaint is being closed since after multiple email attempts to retrieve the product, the product still hasn't been returned for evaluation.If and when the device in question is received, this file will be reopened and its contents made to reflect the results of the evaluation.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed dis-similar complaints for this lot 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.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.(b)(4).This report is being filed from the remetrex complaint management system 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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This is report 1 of 2 for the same event.It was reported by affiliate in (b)(6) that during an unspecified surgical procedure of the wrist, it was observed that the anchor did not fix into the bone.According to the report, it pulled out.It was further reported that it was impossible to set anchor in the bone.It was reported that another device from a different lot was used but the same problem was encountered.No consequences to the patient-another like device was used.It was not reported if there were any delays in the surgical 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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