Model Number 03.100.018 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, the non-acceptance of the instrument with cable in celeron material by the (b)(6) hospital materials center, we consulted with nurse (b)(6), responsible for the technical area of the hospital's materials center.It is a material that has porosity due to exposure to the temperature of the sterilization process.It is the porosity of the celeron that compromises the cleaning process.It was understood then that the material compromises the sterilization process, since it has porosity that does not guarantee the effectiveness of cleaning.If you are not in accordance with the justification presented, i suggest that you present to the hospital technicians responsible, a document with the manufacturer's specifications that meet the standards of the manuals of good cleaning and sterilization practices.This report is for one (1) straight ball spike for low profile pelvic system.This is report 3 of 15 for complaint (b)(4).
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Search Alerts/Recalls
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