Model Number 25-472-05-07 |
Device Problems
Use of Device Problem (1670); Temperature Problem (3022)
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Patient Problem
Burn(s) (1757)
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Event Date 09/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: mdr: 9610905-2018-00236.
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Event Description
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It was reported a patient was burned while using a twist drill and trocar.The twist drill was being used at 20,000 rmps.It is stated in ifu (b)(4) "twist drills are not designed to be used at speeds in excess of 5000 rpm.".
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Manufacturer Narrative
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An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage falls within the design risk limits adhered to at klm.The review of the device history records was not possible due to no lot number being identified.The ifu indicates that drills are not to be used with than 5000 rmp.The provided information reveal that the root cause was an incorrect use by the customer.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
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Search Alerts/Recalls
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