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OBERDORF SYNTHES PRODUKTIONS GMBH DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM; GAUGE, DEPTH
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| Catalog Number 03.019.017 |
| Device Problems
Break (1069); Device-Device Incompatibility (2919)
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| Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/ investigation.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 (b)(6) reports an event as follows: it was reported that on an unknown date that during the cleaning process it was noted that welding seem had burst.There was no patient involvement.This report is for one (1) depth gauge for multiloc humeral nailing system.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, h6: part: 03.019.017, lot: 7550900, manufacturing site: hägendorf, release to warehouse date: 29.July 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The shipped back device ¿depth gauge f/ml hum nail¿ article number 03.019.017 with lot number 7550900 is broken.According to drawing, the two components 60073050 ¿messhaken¿ and 60073052 ¿shaft¿ must be laser welded together in component 60073054 ¿scala with hook¿.However, even if it is visible the melted circle of material laser welded (meaning that the process step was executed), the two components are not connected anymore.Furthermore, the extremity of component 60073050 which should be welded is damaged with small cuts in the material.It looks like the device was welded and only after was damaged.The following documents were reviewed: device history record (dhr) 7793693; inspection sheet ¿aa intern multiple 03.019.017¿; ¿depth gauge expert / asls ¿; ¿scala with hook¿; ¿shaft¿; ¿messhaken / measurung hook¿.In order to perform the investigation, all the documents mentioned above, valid when the device was manufactured, have been analyzed.The manufacturing process was executed according to the analyzed documents and no anomalies were identified.Furthermore, the functionality of the device was tested with 100% frequency and no issue was identified during the manufacturing.A dimensional inspection has been performed on the relevant features in order to see if a dimensional defect potentially contribute to the complaint issue.However, the measured parts are damaged/ broken and, for this reason, the measurements were taken as close as possible to the damaged area.The outer diameter of component 60073052 ¿shaft¿, according to drawing was inside specifications.According to drawing the outer diameter of component 60073050 ¿messhaken¿ was inside specifications.According to drawing the outer diameter of the extremity opposite to the hook of component 60073050 ¿messhaken¿ was inside specifications.Since all the features tested passed the dimensional inspection, no dimensional defect contributes to the complaint condition.According to evidence is not possible to address the final root cause to a manufacturing issue.Most likely a mishandling of the device led to the opening of this complaint.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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It was further clarified that the event occurred during an unknown procedure.During the procedure the welding seem of the instrument has come undone.While trying to remove the depth gauge after measuring the depth of the proximal locking screw the depth gauge got stuck in the bone or the tissue protection sleeve.Surgery was completed successfully without negative patient impact.Concomitant devices reported: screw (part # unknown, lot # unknown, quantity 1); protection sleeve (part # unknown, lot # unknown, quantity 1).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: updated event description.B5, d11: added concomitant devices.D4; h4.E1: added reporter's phone number.H6: added device code.H11 corrected data.A1, b6; b7; e1: reporter's name; e3.G3; h6.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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