Catalog Number 329.634S |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problems
Sedation (2368); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(b)(6).(b)(4).Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4).Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 15-jul-2011, expiration date: 31-may-2020, part #: 329.634s, lot#: 6694806 (sterile) - bending template-stwe f/1.5mm resorb orbital floor pl 35mm.Ncr (b)(4) was created on 16-jun-2011 for "parts are scrached." review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.(b)(4), ¿sterility documentation was reviewed and determined to be conforming.¿ 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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It was reported that the expiration dates printed on the labels of the inner pouches of two rapid resorb orbital floor plates do not match the dates printed on the outer packaging of the rapid resorb orbital floor plates with bending template.The inner pouch packages have an expiration date of august 2015.The outer packaging has an expiration date of may 2020.This was identified when one of the plates was opened during a left orbital floor blowout fracture repair on (b)(6) 2016.The plate and included template were placed into a warming bath for molding on the sterile field and were placed into the patient's orbital socket for a test fit.It was then realized that the product packaging included an expired expiration date.The surgical field was considered contaminated, and the patient is considered at risk of infection.Another orbital floor plate package bearing the same part and lot combination was opened as a comparator.Again, the same expired expiration date was identified on the inner pouch.It was decided that neither of these two plates would be utilized in the procedure.A titanium orbital plate and screws from a craniomaxillofacial (cmf) tray were implanted.There was a reported 30 minute surgical delay.The procedure was completed without further incident and with the patient in stable condition.This complaint involves four devices.This report is 3 of 4 for (b)(4).
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Manufacturer Narrative
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Product investigation summary: it was reported that the expiration dates printed on the labels of the inner pouches of two rapid resorb orbital floor plates do not match the dates printed on the outer packaging of the rapid resorb orbital floor plates with bending template.The inner pouch packages have an expiration date of august, 2015; the outer packaging has an expiration date of may, 2020.Six devices were received with a complaint category "labeling: content." this complaint is confirmed as visual inspection shows that the inner pouch label expiry dates do not match the outer packaging label expiry dates.Whether this complaint can be replicated at customer quality (cq) is not applicable.A delivery stop and screening notice have been initiated in order to address this concern.The awareness date of the reported event was march 15, 2016.Notification/awareness of this particular part was april 6, 2016.Device is an instrument and is not implanted or explanted.Device 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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This report is 5 of 6 for (b)(4).
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Search Alerts/Recalls
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