OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L90 TAN; APPLIANCE,FIXATION,NAIL/BLADE
|
Back to Search Results |
|
Catalog Number 04.027.033S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
Patient information is not available for reporting.This report is for unknown pfna head element/unknown lot number.Portion of the device is still implanted in the patient, another removal is planned.(b)(6).Patient code (b)(4) used for: the patient had post-operatively pain, there is no allegation of a complaint against this device; however, because this device is dwelling in the area of the reported event it cannot be disassociated from the reported adverse event.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate 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 on an event in (b)(6) as follows: it was reported that the patient had post-operativey pain and thought this was because of the implanted proximal femoral antirotation (pfna) implants.A planned removal surgery was performed on (b)(6) 2017 but they were unable to remove the blade (see (b)(4)).They could not remove the blade and closed the site, another removal is planned.No information available about patient condition.This complaint involves 3 parts.This report is 3 of 3 for (b)(4).
|
|
Manufacturer Narrative
|
Date of explant is unknown.The device was received and the product evaluation is in progress.No conclusion can be drawn.Device is not distributed in the united states, but is similar to device marketed in the usa.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
|
It was further reported that on an unknown date, patient underwent removal of the blade.During the removal of the blade, the hook was stuck into blade while using blade removal tool to get the blade out.This incident is captured under linked (b)(4).Concomitant devices reported: hook f/removal of pfna-blades (part# 03.010.172, lot# l347972, quantity 1).Guide/compression/k-wires (part# unknown, lot# unknown, quantity 1).
|
|
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.Device history records review was completed for part# 04.027.033s, lot# 9108456.Manufacturing location: bettlach, release to warehouse date: aug 19, 2014, expiry date: aug 01, 2024.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.The visual inspection of the returned part showed strong damages on the surface of the blade, possibly while trying to remove the implant with a pliers f/removal of pfna-blades.Additionally, it was visible that the extraction hook was bent and stuck inside the blade together with an unknown guide wire.The tip section of the extraction screw 03.010.411 was also visible being stuck inside the blade.As all the parts were stuck tight together, parts could not be detached.The review of the production history of the pfna blade 04.027.033s revealed that this implant was manufactured in august 2014 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.Unfortunately, the cause of the pain could not be determined based on the information provided.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Previously reported concomitant devices - hook f/removal of pfna-blades (part# 03.010.172, lot# l347972, quantity 1).Guide/compression/k-wires (part# unknown, lot# unknown, quantity 1) are not concomitant in this incident as this report is for patient pain.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
|
|
|