Catalog Number A2114 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 several staff reported observing the locking knob of the mayfield skull clamp (product id a2114) spinning continuously without engaging the locking mechanism.However, the facility's internal evaluation found that the skull clamp was locking as it should, but that the ratcheting locking knob does not seem to be engaging to catch the teeth on the other arm.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
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Event Description
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N/a.
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Manufacturer Narrative
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Unique device identifier (udi): (b)(4).Device history record (dhr) - the dhr shows no abnormalities related to the reported failure.Mayfield infinity skull clamp (a2114) was returned for evaluation.The reported complaint was confirmed via inspection of the unit.Unit received with the left and right pawls broken.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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Search Alerts/Recalls
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