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Catalog Number 07.702.016S |
Device Problems
Improper Chemical Reaction (2952); Failure to Eject (4010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
Event Type
malfunction
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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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter facility name: (b)(6) hospital.E3: reporter is a j&j employee.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: 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 history review (dhr): part # 07.702.016s.Lot # 3b53590.Manufacturing site: werk selzach.Release to warehouse date: 03.Feb.2023.Expiration date: 01.Feb.2026.Supplier: osartis gmbh.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 japan as follows: it was reported that on (b)(6) 2023, the surgeon tried mixing the cement in question after adding all the liquid, but the handle did not move at all.He always moves the handle at a slight angle, but this time the handle did not move at all, so a spare product was used.Regarding the spare cement in question, the surgeon spilled a little liquid, which resulted in the cement with less moisture than usual, and when filling the syringe, it was very hard and not much cement came out.The patient outcome was reported to be stable.This report involves one vertecem v+ cement kit.This is report 2 of 2 for (b)(4).
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Search Alerts/Recalls
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