Model Number A3059 |
Device Problems
Mechanical Problem (1384); Noise, Audible (3273)
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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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The mayfield composite series skull clamp (a3059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.The unit received had a sticking index knob and the teeth were not meshing.The lock ratchet was replaced due to worn teeth and general maintenance and cleaning were performed.Root cause - complaint is confirmed via inspection of the unit.Unit received had a sticking index knob and the teeth were not meshing.The lock ratchet was replaced due to worn teeth.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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Event Description
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A facility reported that the black locking knob on the mayfield composite skull clamp (a3059) makes a squeaking sound when being locked and unlocked.It is also difficult to turn black locking knob into the locked position.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.
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Search Alerts/Recalls
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