Catalog Number 03.804.702S |
Device Problem
Deflation Problem (1149)
|
Patient Problem
No Code Available (3191)
|
Event Date 08/29/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Additional device product code: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.
|
|
Event Description
|
Device report from synthes reports an event in (b)(6) as follows: it was reported that during an unknown procedure on (b)(6) 2019 with the synflate system, it was impossible to deflate three (3) synflate l balloons in the vertebra.It was not possible to remove the synflate balloons with the working trocar.The procedure was completed by pulling the not completely deflated balloon to the top of the working trocar (3x) and completely removing both the trocar and the balloon.Procedure was delayed by thirty (30) minutes.Procedure was completed successfully by using same like product.Patient outcome is reported as stable.Concomitant device reported: balloon inflation system (part# unknown, lot# unknown, quantity 1); unknown torcar (part# unknown, lot# unknown, quantity 3).This report is for one (1) synflate balloon/large-sterile.This is report 1 of 3 for complaint (b)(4).
|
|
Manufacturer Narrative
|
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.Part number: 03.804.702s, lot number: 0818005, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 17.Sep.2018, expiry date: 01.Aug.2020.A manufacturing record evaluation was performed for the finished device lot number, 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.
|
|
Search Alerts/Recalls
|
|