DEPUY SYNTHES PRODUCTS LLC CHUCK WITH KEY/DRILL SPEED FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.206 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).Reporter¿s phone number was not provided.Concomitant med products and therapy dates: battery handpiece device, lid device, power module device, coupling devices and attachment device.(b)(6) 2019.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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This is report 4 of 6 for the same event.It was reported from (b)(6) that during an unspecified orthopedic surgical procedure, it was observed that the battery handpiece device while being used with a lid device, power module device, (2) coupling devices and (2) attachment devices became hot and was emitting a loud sound.There were no reports of delays in the surgical procedure.It was not reported whether a spare device was available for use.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: device history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.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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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Corrected data g4: it was reported in the initial medwatch that the date received by the manufacturer was noted as september 27, 2019 and has been corrected to august 16, 2019.H4: the device manufacture date was documented as unknown in the initial report.It has been updated to may 16, 2018.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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