Catalog Number 400.834 |
Device Problem
Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Synthes sales representative.The investigation could not be completed; no conclusion could be drawn, without a lot number the device history records review could not be completed.Product was not returned.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.
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Event Description
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It was reported that on (b)(6) 2018, two synthes low profile cranial screws plus drive self-drilling were faulty.One had a dented tip that could not be used and the other had a faulty screw head that could not be picked up by the screwdriver.It was unknown when the issue occurred and if there was a patient involvement.Concomitant device reported: unknown screwdriver (part #: unknown, lot #: unknown, quantity: 1).This report is for one (1) ti low profile neuro screw self-drilling 4mm.This complaint involves two (2) device.This report is 2 of 2 for (b)(4).
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Event Description
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The screws were not used on the patient, as prior to insertion, it was found that the screws were faulty.It was unknown if there was a patient involvement.There was no reported delay of any case due to the product quality issue.There was no patient consequence.
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Manufacturer Narrative
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Investigation summary: visual inspection: the received cranial-screw plusdrive ø1.6 self-drill l4 beside some marks and deformation of the screw head recess is intact.The cruciform head recess is damaged.The side walls of the cross slot have displaced metal in the clockwise and anti-clockwise direction relative to torque applied and presenting mechanical overload while use.Dimensional inspection: the head diameter and screw length were measured and found to meet the specifications target dimension of head diameter 2.9 +0.05 / -0.10 mm.Actual dimension of head diameter 2.94 mm / pass.Target dimension of screw length: 4 +0.5 mm.Actual dimension of screw length: 4.21 mm / pass.Drawing/specification review: the cause of the complained malfunction is a post-manufacturing caused damage due to mechanical overload to the device, therefore no drawing/specification review is required conclusion: the investigation shows that the screw is in used condition as the cross recess show marks and displaced material from screw drivers presenting mechanical overload.The screw driver therefore does not engage in the head recess anymore and the complaint can be confirmed.Based on the condition of the product and the available information a manufacturing conclusion cannot be presented.The root cause of this event is determined to be mechanical overloading while use.The low profile neuro instructions for use contains the following warning note: ¿be aware that implants ae not as strong as native bone.Implants subjected to substantial loads may fail.¿ based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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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