Model Number A1059 |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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It was reported that the c-clamp on the mayfield modified skull clamp (a1059) does not lock tight enough and the swivel arm is able to be loosened too easily.Also, the ratcheting system is too rough.The facility has not reported if there was patient involvement, injury or surgical delay relative to this event.
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Manufacturer Narrative
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The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: on investigation of the unit it was discovered that the lock had rotational and lateral movement, but a residue buildup was present and index knob was discovered to be loose.New components were added to replace worn internal parts.General maintenance and cleaning performed.Root cause: complaint confirmed via inspection of the unit.There was movement present in the lock, index knob was loose and required replacement of worn internal parts from routine use and wear.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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Event Description
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N/a.
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Search Alerts/Recalls
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