Catalog Number 338.110 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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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It was reported that the customer reports that during the dhs (dynamic hip screw) surgery, many issues occurred with the ancillary.The triple reamer did not advance during implantation of the cephalic screw (12.5 mm diameter lag screw) and it was impossible to slide the plate on the screw.It was impossible to perform the osteosynthesis without bone damages.The surgeon replaced the ancillary, the plate and the screw.This report is for one (1) dhs reaming head.This is report 4 of 6 for (b)(4).
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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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
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Event Description
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11/23/2018: updated event description: it was reported that on (b)(6) 2018, during the dhs (dynamic hip screw) surgery, many issues occurred with the ancillary.The triple reamer did not advance during implantation of the cephalic screw (12.5 mm diameter lag screw) and was impossible to slide the plate on the screw.In addition, osteosynthesis was impossible to perform without bone damages.The surgeon replaced the ancillary, plate and screw.It is unknown if there was a surgical delay.Patient outcomes was unknown.This complaint involves six (6) devices.
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Search Alerts/Recalls
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