OBERDORF SYNTHES PRODUKTIONS GMBH 12MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY
|
Back to Search Results |
|
Catalog Number 04.037.226S |
Device Problem
Break (1069)
|
Patient Problem
No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.
|
|
Event Description
|
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the patient will undergo a revision surgery due to a twice broken trochanteric fixation nail advance (tfna) nail at the aperture.Primary surgery was on (b)(6) 2018.It is unknown when the first breakage happened.The patient will be revised with a femoral recon nail (frn).Concomitant devices reported: 40mm locking screw (part# 04.005.530s, lot# l702526, quantity: unknown).46mm locking screw (part# 04.005.536s, lot# l694087, quantity: unknown).Tfna end cap (part# 04.038.000s, lot# l579683, quantity: 1).Unknown plate (part# unknown, lot# unknown, quantity:1).Unknown screw (part# unknown, lot# unknown, quantity:4).This complaint involves (1) device.This report is 1 of 1 for (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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device history review 10-dec-2018: dhr reviewed.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history manufacturing location: monument, manufacturing date: 19-oct-2017, expiration date: 01-oct-2027, part number: 04.037.226s, 12mm/125 deg ti cann tfna 360mm/right- sterile, lot number: h478712 (sterile), lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final ns063055 rev h met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label was reviewed and determined to be conforming.Scn supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Investigation summary - complaint is confirmed as we are able to confirm complaint description (broken nail) based on the received pictures.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.
|
|
Search Alerts/Recalls
|
|
|