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Catalog Number UNK PERFORATOR |
Device Problem
Material Fragmentation (1261)
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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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Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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As reported by the affiliate, a codman perforator came apart where the shank is connected to the chuck of the hand drill and was unable to be re-attached ed to the hand drill.The bit had to be removed by hand.There is no report of further intervention needed or injury to the patient.
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Manufacturer Narrative
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Complaint sample was not returned to codman and no valid lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
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Search Alerts/Recalls
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