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Catalog Number 292.620S |
Device Problems
Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)
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Patient Problem
No Code Available (3191)
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Event Date 01/07/2020 |
Event Type
Injury
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Manufacturer Narrative
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Patient's birth year reported as (b)(6).Additional device product code: hty.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the two (2) 2.7mm perforated drill bits were not permeable.They were obstructed by a threaded pin of diameter 1.25mm.Instruments have not been properly disassembled, cleaned and reprocessed during sterilization process.There was difficulty controlling on the block.Patient's consequence reported as risk of infection and exposure to the patient's blood.No further information provided.Concomitant devices reported: drill bit ø2.7/1.35 cann l160/130 4flut (part # 310.670, lot # unknown, quantity 2); guidewire ø1.25 w/thread-tip w/trocar l1 (part # 292.620s, lot # unknown, quantity 1).This report is for one (1) 1.25mm threaded guide wire 150mm.This is report 2 of 4 for complaint (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.Picture review: the narrative could not be confirmed from the provided picture.Due to the quality of the picture the reported problem could not conclusively be confirmed.Product was not returned.Based on the information available, it has been determined that no corrective and 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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Search Alerts/Recalls
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