|
OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L85 TAN; ROD, FIXATION, INTRAMEDULLARY
|
Back to Search Results |
|
| Catalog Number 04.027.032S |
| Device Problem
Device-Device Incompatibility (2919)
|
| Patient Problem
No Consequences Or Impact To Patient (2199)
|
| Event Date 09/16/2020 |
|
Event Type
malfunction
|
|
Manufacturer Narrative
|
|
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.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 a surgery on (b)(6) 2020, the impactor could not be disconnected from the proximal femoral nail antirotation (pfna) blade anymore.The blade and the impactor had to be removed from the patient.Also stuck to the blade and impactor are the buttress/compression-nut and the protection sleeve.A new instrument and a new blade was used.Surgery completed successfully with a delay of thirty (30) minutes.No adverse patient harm.Patient status good, as intended.This report is for one (1) pfna blade perf l85 tan.This is report 4 of 4 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.D10, h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.
|
| |
|
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.H3, h6: a product investigation was conducted.Visual inspection: the returned pfna - blade was received with an assembled condition of impactor / protect sleeve and buttress/compr-nut.Further investigation has shown that on the sleeve as well as the tip of the pfna blade are wear marks visible.The anodized layer is worn away at the marks, which indicates that it was caused post-manufacturing.Functional test: the device was reassembled before the functional check could be executed.The function test at zuchwil customer quality was conducted with the returned instruments (impactor) with the result that the blade could be locked / unlocked as per design intended.The complained malfunction of "the impactor could not be disconnected from the blade anymore." could not be replicated.It was possible to attach the blade to the impactor without any issues and the tip of the pfna blade did rotate freely after attaching as required.Also the blade was locked as required after the impactor was removed.Summary: the complaint is not confirmed as the received pfna blade is functional as required.The root cause of the complained malfunction cannot be defined as it was not possible to replicate the occurrence with the returned devices.We can only assume that there was a complication during the surgery that caused this problem.Based on our investigations, we only can determined that possibly an insufficient contact with protect sleeve to the bone during the entire of the blade which finally lead to the occurrence.In this relation we would like to mention following important statement of the pfna surgical technique ¿se_822673aaeng.Pdf¿, page 23: - note: the sleeve assembly must be in contact with the bone during the entire blade implantation.Do not tighten the buttress nut too firmly as this could impair the precision of the insertion handle and sleeve assembly.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "document/specification review: / dimensional inspection:" are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part: 04.027.032s, lot: 61p2018, manufacturing site: bettlach, release to warehouse date: 14.July 2020, expiry date: 01.July 2030.A manufacturing record evaluation was performed for the finished device 04.027.032s, lot: 61p2018 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
|
|
|
