The mayfield infinity skull clamp (a1114) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The definite root cause cannot be identified as the device was not returned.However, a probable root cause for the reported complaint is improper or suboptimal placement of the skull clamp on the patient.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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Additional information received indicating the following: 1.When placing the skull clamp, if you were to draw an imaginary line between the single pin and the rocker arm swivel point, did that imaginary line pass through an axial center of the skull? yes.2.Did each pin engage the cranium in a perpendicular approach? yes.3.Was there a delay in surgery due to product problem? yes, 30 min.4.Was there any patient adverse consequence because of the delay? no.
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