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Device Problem
Crack (1135)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Event date: unknown date in 2018.This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Initial reporter is synthes sales representative.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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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, the patient underwent an unknown procedure.The screw issue on a variable angle locking compression olecranon plate was where the screw ran from proximal plate end towards ulna diaphysis.Upon screw insertion, the unknown locking screw distal thread was detaching from the screw shaft and the screw was no longer considered as locked screw.The surgeon wanted to put a locking screw through most of the proximal hole in order to reach the diaphysis rather than the throchlea.They needed to angulate the screw more than the allowable fifteen (15) degrees.The surgeon insisted on inserting the screw in that condition which then caused all of the screw thread to peel off.The surgeon then decided to use an unknown plate and screw construct (accumed) in order to complete the procedure.It is unknown if there was surgical delay.Patient and procedure outcome are unknown.Concomitant device reported: variable angle locking compression olecranon plate (part# 02.107.202, lot# unknown, quantity#) this report is for one (1) unknown- screws: locking 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.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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Synthes devices were implanted successfully and no non-synthes devices were used.
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Search Alerts/Recalls
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