Model Number 2.7/3.0/3.5/4.0MM DEPTH GUIDE, 100MM |
Device Problems
Incorrect Measurement (1383); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2022 |
Event Type
malfunction
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Event Description
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On (b)(6) 2022, it was reported by a sales representative via sems that a ar-8963-01 depth guide mis measured.This occurred on (b)(6) 2022 during a pilon fx when reviewing the final xray it was found that the screws lengths were much shorter than the measurement of the depth gauge.The screws were removed and remeasured with a different depth gauge.There was no additional information provided.Additional information provided on 10/19/2022, it was reported that additional anesthesia was administered due to the 15 minute delay.A working depth gauge was brought in to complete the case.The gauge was measuring 10mm short for every screw length.When the depth gauge is measuring at the 10mm you can't see the metal end.
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Manufacturer Narrative
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Complaint is confirmed.One unpackaged ar-8963-01, batch number: 012043, was received for investigation.Functional testing cannot be performed because of the bend.The instrument was bent previously received for the investigation.Visual evaluation found that the needle is bent and doesn't let the slider move freely.The observed event is most likely caused by excessive bending forces applied during use.
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Search Alerts/Recalls
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