OBERDORF SYNTHES PRODUKTIONS GMBH QUARTER-TUBULAR PLATE WITH COLLAR 6 HOLES/47MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
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Catalog Number 242.06 |
Device Problem
Break (1069)
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Patient Problems
Failure of Implant (1924); Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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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.Without a lot number the device history records review could not be completed.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.(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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, that the patient experienced post-op pain due to a broken plate.On (b)(6) 2019 the patient had an open reduction internal fixation (orif) procedure for a right second metacarpal fracture.During the procedure a 1/3 tubular plate and six (6) screws were implanted.Approximately, four (4) weeks after the procedure the patient experienced pain and it was discovered that the plate was broken.On (b)(6) 2020 the patient had an orif revision surgery and received a new plate and screws.The patient was reported as safe and was experiencing slow recovery.Concomitant devices reported: cortscr ø2.7 l12 sst (part number 202.012, lot unknown, quantity 2) screws (part number unknown, lot unknown, quantity 4).This report involves one (1) ¼-tub-pl 2.7 6ho l50 sst.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.H3, h4, h6- the quarter tubular plate is broken as complained.The breakage occurred at the third hole.The plate presents mechanical damages such as nicks and scratches especially at the area of the breakage ¿ unknown if they occurred during implantation or explantation.Summary: the complaint condition is confirmed as the quarter tubular plate was found broken.The for the complaint relevant dimensions were checked as far as possible and found to be within specifications.This lot was manufactured in april 2002 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The correct material was used.A manufacturing related issue can be excluded.We would also like to point out that it is not advisable to mix synthes products with those of different manufacturers, since designs, materials, mechanics, and constructions are not harmonized.Synthes assumes no liability for any complications arising from mixing components or from using devices from other manufacturers (for further information please see important information leaflet).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: 242.060, lot: 2031198, manufacturing site: bettlach, release to warehouse date: 09 april 2002.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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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.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: cortscr ø2.7 l12 sst (part# 202.012, lot# 2066980, quantity# 1); cortscr ø2.7 l12 sst (part# 202.012, lot# 2071958, quantity# 1) and unknown screws (part# unknown, lot# unknown, quantity# 4).
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