OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L100 SST; ROD, FIXATION, INTRAMEDULLARY
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Catalog Number 02.027.035S |
Device Problem
Device Slipped (1584)
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Patient Problem
No Code Available (3191)
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Event Date 01/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Case number for implantation procedure reported as (b)(6).Date of event is an unknown date in 2019.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that patient was treated for a left sided pertrochanteric femur fracture on the (b)(6) 2019.A proximal femoral nail antirotation (pfna) nail and blade were inserted to fix the fracture.Postoperatively, the patient experienced pain, and it was noted that the blade had moved into the hip joint.Revision surgery was performed on (b)(6) 2019.Concomitant devices: screw (part: 259.400, lot: 3l77106, quantity: 1), proximal femoral nail antirotation (pfna) nail (part: 272.266s, lot: 4l08383, quantity: 1).This report is for a pfna helical blade.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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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.The pfna blade was received in a locked condition.On the sleeve of the pfna blade are slightly wear marks visible.No other visual damage could be observed at the blade.The function test at zuchwil customer quality was conducted with a demo impactor with the result that the blade could be locked / unlocked as per design intended.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.No manufacturing related issues that would have contributed to this complaint were found.The complaint is confirmed as the attached x-rays could be verified as implant migration.But the complaint is rated as unconfirmed for this pfna blade based that the blade is functional as required.We cannot determine the exact root cause of the complained issue "implant migration".By the x-rays review it seems that the pfna blade is locked as intended.Finally we are based on the provided information we are not able to determine the exact cause of this occurrence.We can only assume that there was a complication during the healing process that caused this problem.Postoperative activities of the patient and a possible instability of the fracture situation (poor bone density) may have played a certain role, too.Since not all of them can be investigated and excluded from the root cause analysis, no final statement about the cause of such issues of pfna blade migration can be made.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is 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.Device history lot part: 02.027.035s, lot: 3l77106, manufacturing site: bettlach, release to warehouse date: 13 march 2019, expiry date: 01 march 2029.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.
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Event Description
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Concomitant devices reported: unknown screw (part # unknown, lot # unknown, quantity # 1), proximal femoral nail antirotation (pfna) nail (part # 272.266s, lot # 4l08383, quantity # 1), bolt (part # 259.400, lot # l930833, quantity # 1).
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