OBERDORF SYNTHES PRODUKTIONS GMBH 22MM COCR RADIAL HEAD 2MM HT EXTENSION/14.5MM-STER; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
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Catalog Number 09.402.222S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) reports an event as follows: it was reported that on an unknown date, a patient with implanted radial head required surgical or medical intervention.This report is for a 22mm cocr radial head.This is report 1 of 2 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, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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.H3, h4, h6: a review of the device history record.Device history lot manufacturing location: supplier - (b)(4), packaged and released by: monument.Release to warehouse date: 10-feb-2015, expiration date: 31-jan-2020, part number: 09.402.222s, 22mm cocr radial head 2mm height extension/14.5mm ¿ sterile, lot number: 7765616 (sterile), lot quantity: 50.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated 19-jan-2015 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, ns051180 rev c met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev b was reviewed and determined to be conforming.Scn 10992 supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 21022, tialnbri8.00, lot number: 5345317, lot quantity: 4,257 lbs.Product traveler met all inspection acceptance criteria.Raw material inspection sheet, rmtialnbri8_00 rev j met all inspection acceptance criteria.Certified test report supplied by perryman company dated 18-sep-2006 and inspection certificate supplied by vsmpo dated 10-apr-2006 were reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Part number: 41060, cocrmori25.40, lot number: 7695678, lot quantity: 976 lbs.Certificate of tests supplied by carpenter dated 09-may-2014 was reviewed and determined to be conforming.Lot summary report dated 20-may-2014 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history batch null, device history review 09-sep-2019: this lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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.Manufacturing location: supplier - (b)(4), packaged and released by: monument, release to warehouse date: 10-feb-2015, expiration date: 31-jan-2020, part number: 09.402.222s, 22mm cocr radial head 2mm height extension/14.5mm ¿ sterile, lot number: 7765616 (sterile).This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 21022, tialnbri8.00, lot number: 5345317.Part number: 41060, cocrmori25.40, lot number: 7695678.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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