Model Number A1059 |
Device Problem
Mechanical Problem (1384)
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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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A facility reported that the ratchet mechanism on the mayfield modified skull clamp (b)(4) jumps when opening and closing and the pressure pin is losing pressure.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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Mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis: the complaint is confirmed via inspection of the unit.The investigation showed that the lock had rotational and lateral movement and a residue buildup was present.The ratchet extension was not moving smoothly in the body casting.General maintenance and cleaning performed; new components were added to replace worn internal parts.Root cause analysis: probable root cause includes rough handling and routine wear of the device.Unit required maintenance and replacement of worn components.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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Search Alerts/Recalls
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