SYNTHES GMBH 2.7MM/3.5MM VA-LCP MEDL DSTL HUM PL 4H/RT/108MM-LONG-STER; PLATE, FIXATION, BONE
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Catalog Number 02.117.404S |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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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 on an unknown date, the patient¿s plate broke post-op.The patient is scheduled for a removal procedure.This report involves one (1) 2.7mm/3.5mm va-lcp medl dstl hum pl 4h/rt/108mm-long-ster.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Additional device product codes: hwc.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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.H3, h6: part: 02.117.404s, lot: 1l51310, manufacturing site: werk mezzovico, release to warehouse date: september 21, 2018, expiry date: september 01, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the va-lcp dhp 2.7/3.5 med r long 4ho l108 s was returned for investigation.A visual inspection noted that the device was broken into two pieces.There were also light surface scratches on the device consistent with implantation and removal.Theses scratches likely did not contribute to any device failure.No other defects were noted.Dimensional inspection: a dimensional inspection could not be performed due to device geometry and post manufacturing damage.Document / specification review: the current and manufactured documents were reviewed in the investigation.No design or manufacturing discrepancies were noted.Investigation conclusion: the complaint is confirmed as the device was broken.No definitive root cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.H3, h6: the subject device has been 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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