WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPLETE RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 03.037.012 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Initial reporter is synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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 reported that on (b)(6) 2020, the sales consultant was performing a demo for the surgeon when it was noticed that the drill bit was hitting the nail on the distal locking screw on a short tfna.There was no patient involvement.Concomitant devices reported: unknown locking screws (part# unknown, lot# unknown, quantity# 1).This report is for 1 complete radiolucent insertion handle.This is report 1 of 4 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: h3, h4, h6 investigation summary visual inspection: the complete radiolucent insertion handle (p/n: 03.037.012, lot number: 9921276 ) was received at us cq.Visual inspection of the complaint device showed some scratches on the bottom of the handle that would not impact functionality or alignment.Functional test: a functional assessment was unable to be performed on the complaint device since all the mating devices were not returned.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? no investigation conclusion: this complaint is not confirmed as a functional test could not be performed and there is no damage that would impact functionality/alignment.No definitive root cause could 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 history part: 03.037.012 lot: 9921276 manufacturing site: hägendorf release to warehouse date: 26 july 2016 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.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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Search Alerts/Recalls
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