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.E3: initial reporter is a synthes employee.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h6: 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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 07.702.016s; lot: 2k53550; manufacturing site: werk selzach; release to warehouse date: 18.Oct.2022; supplier: (b)(4); expiration date: 01.Oct.2025.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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Device report from japan reports an event as follows: it was reported that the patient underwent a percutaneous vertebroplasty (th11) for a compressed fracture on (b)(6) 2023.The surgery was performed via vbs system.When the cement was mixed using the mixture in question, the handle became stuck.There was no impact on the procedure or patient, a spare product of the same type was used.The procedure was completed successfully with no surgical delay.No further information is available.This report is for a vertecem v+ cement kit.This is report 1 of 1 for (b)(4).
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