(b)(4).The perforator was returned for evaluation.Device history record (dhr)- there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis- the perforator unit was inspected using the unaided eye: no anomalies were observed, received disassembled with damage to the outer drill (not related to manufacturing), no sleeve, no pin and had organic matter.Ifu testing procedure was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria once reassembled as it could not be tested in as-is condition.The returned unit was found to work as intended, and met all acceptance criteria.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.
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Updated fields: d4, d10, g4, g7, h2, h3, h4, h6, h10.Unique device identifier (udi)- ((b)(6).Additional information received on 08 july 2020, stating that no treatment was done.Over time the tear that was caused closed.Another craniotomy kit was used to guarantee patient care.Perforator was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.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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