DEPUY SYNTHES PRODUCTS LLC POWER MODULE FOR TRAUMA RECON SYSTEM; BATTERY, REPLACEMENT, RECHARGEABLE
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Catalog Number 05.001.202 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).Concomitant med products and therapy dates: power module device and battery handpiece devices (b)(6).Reporter¿s complete mailing address was not provided.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.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 3 of 4 for the same event.It was reported from (b)(6) that the two battery handpiece devices and two power module devices did not work, stopped operation and were difficult to connect to the handpiece.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available has been disclosed.If additional information were to 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.The actual device was returned for evaluation.During evaluation it was observed that the device passed all manufacturing specifications.Therefore, the reported condition was not duplicated and confirmed.An assignable root cause was not determined.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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