DEPUY SYNTHES POWER TOOLS LINDEMANN REAMER M Ø 2.3MM HEAD LENGTH 20.2MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 03.000.113S |
Device Problems
Break (1069); Material Discolored (1170)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).The manufacturing location was unknown.The device manufacture date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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This is report 1 of 2 of the same event.It was reported from (b)(6) that during an unspecified pediatrics surgical procedure, it was discovered that the reamer device broke and a second reamer device was discolored at the tip.During subsequent follow-up with the customer, it was confirmed that one of the reamer devices was discolored.It was further reported that the discoloration could be due to hear or corrosion; however, the reporter could not confirm it the discoloration was from overheating.There was a thirty minute delay to the planned surgical procedure.A spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.The procedure was completed successfully.There was no undesirable outcome.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device broke off at the connection between reaming part and the shaft.That indicates that the reamer may have been subjected to high physical force during reaming.The breaking of the tip is most likely due to improper use, like the reamer has been used for drilling, with too high speed or with too much sideward pressure.The reamers are not suitable for drilling as the tip is not sharpened.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper use (use error).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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