Model Number 261221 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2022 |
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 physician reported a perforator (id 261222) couldn't drill the bone.The physician felt the perforator was too dull and had difficulty in perforating during a procedure.According to information provided, it is unknown the manufacturer of the drill used with the perforator and if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.The procedure was completed with a replacement product.No patient injury reported and the event did not lead to surgical delay.
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Manufacturer Narrative
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The disposable 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: visual inspection utilizing unaided eye was performed.Unit was lightly soiled, but no other anomalies were observed.Spring test attempted.Unit passed the spring test and functioned as designed; functional test was performed, and unit successfully drilled 5 holes and was found to function as intended.The complaint condition could not be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.
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Search Alerts/Recalls
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