SYNTHES GMBH PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS; CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY
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Catalog Number 03.168.013 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation could not be completed, no product was received.No conclusion could be drawn at the time of filing this report.Device history lot part: 03.168.013, lot: 180067-106, manufacturing site: selzach.Supplier: leitner ag.Release to warehouse date: july 19, 2018.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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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation surgery for the femoral neck medial fracture with the drill bit and sleeve in question.During the screw insertion, the surgeon tried to assemble the drill bit to the sleeve, but when the drill bit was inserted to the sleeve halfway, he couldn't push and pull the drill bit and it stuck to the sleeve.The surgeon removed the devices and implants once, and he could dissemble the drill bit from the sleeve.The surgeon tried to assemble them again out of the body, but he couldn't, too.The surgeon continued the surgery without using the drill bit and sleeve and the surgery was completed successfully.After the surgery when the surgeon tried to pass the drill bit through the sleeve, he had difficulty in assembling them, but he could pass the drill bit through the sleeve.No further information is available.Concomitant device reported: unknown screw (part#: unknown, lot#: unknown, quantity: 1.This complaint involves two devices.This report is for (1)protection sleeve f/insertion instr.This report is 2 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: d7 h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.D1.
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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, h6: part: 03.168.013 lot: 180067-106 manufacturing site: selzach supplier: leitner ag release to warehouse date: july 19, 2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.Depuy synthes then conducted visual and functional inspection of the returned device.Visual analysis of the returned protection sleeve determined that the edge at the forefront has a strong deformation.Otherwise, the device is in a good condition with no visible damages, except some slight wear marks.A functional test with the also received drill bit was performed; the drill bit could be inserted and removed without any issues.It was not possible to reproduce the complained malfunction.The deformation at the forefront of the received sleeve has in the received condition no influence on the functionality.Nevertheless, the complaint is rated as confirmed as the visual damages at the shaft of the drill bit indicate that there was an issue during the procedure.This issue was clearly caused by the deformation at the sleeve.The deformation was clearly caused post-manufacturing, either by a hit with another instrument or a drop to the ground.As part of depuy synthes quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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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