OBERDORF SYNTHES PRODUKTIONS GMBH 135 DEG LCP DHS PLATE-STANDARD BARREL 2 HOLES/60MM-STERILE; PLATE, FIXATION, BONE
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Catalog Number 02.224.222S |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
No Consequences Or Impact To Patient (2199); Not Applicable (3189)
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Event Date 10/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Reporter is a synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 synthes reports an event in the (b)(6) as follows: it was reported that a dhs screw did not fit in the dhs plate after handling it correctly.No patient consequence.This is 2 of 2 for report (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
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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.Investigation site: cq zuchwil, selected flow: device interaction ¿ unable to assemble.Visual inspection: the received lcp dhs-plate 135° was found in good condition.A visual inspection was performed, and no damage could be detected.Functional test: function test was performed with a corresponding demo dhs/dcs screw and did not show any abnormalities, the proper function is ensured.Investigation performed within pi-(b)(4) confirmed that the complained malfunction is a result of the deformation at the dhs/dcs screw.Document/specification review: the returned lcp dhs-plate was manufactured in december 2018 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformity noted.Summary:.The complained malfunction is not related to the lcp dhs-plate, therefore the complaint is unconfirmed for the plate.A function test was performed with a corresponding demo dhs/dcs screw and did not show any abnormalities, the proper function of the lcp dhs-plate is ensured.The manufacturing documents were reviewed and no complaint related issues were found.The relevant dimensions were checked and no deviation was found.No product related issue could be detected.The complained malfunction was clearly caused by the deformation at the dhs/dcs screw.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed (pictures attached within pi-(b)(4)).Device history lot part: 02.224.222s, lot: 2l15194, manufacturing site: grenchen, release to warehouse date: dec 04, 2018, expiry date: nov 01, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance 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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Search Alerts/Recalls
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