Catalog Number 400.833 |
Device Problems
Break (1069); Naturally Worn (2988)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received.(b)(6).Without a lot number the device history records review could not be completed.Investigation summary investigation selection.Investigation site: (b)(4).Selected flow(s): 5.Broken.Visual inspection: upon visual inspection: we have received seven (7) screws, three (3) 400.833 and four (4) 400.834, with no lot number reported/provided for investigation.Every screw has a broken off tip, just a bit of the shank is still visible on the screw head (we do not know where the missing parts are).Furthermore, all recess's show signs of usage, a few are even badly worn.This thus confirming the complaint description.Document/specification review: not required per selected investigation flow, as it is a post-manufacturing caused use related damage at the device.Dimensional inspection: not required per selected investigation flow, as it is a post-manufacturing caused use related damage at the device.Material or hardness review: not required per selected investigation flow, as it is a post-manufacturing caused use related damage at the device.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.Unfortunately, we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place or/and that during the operation excessive force (too much mechanical force whilst inserting into the bone) led to this damage.As these screws are very small and quite fragile, a lot of care is required while handling.We can confirm the visible damages are not from any manufacturing non-conformity.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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during an unknown procedure, the seven (7) cranial screws got damaged while tapping.It was unknown if there was a surgical delay.Patient outcome was unknown.This report is for (1) ti low profile neuro screw self-drilling 3mm.This complaint involves seven (7) devices.This report is 1 of 7 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.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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The procedure was successfully completed using another screw which was available in the set.There was no surgical delay.Patient outcome was good.Concomitant devices: screwdriver (part: unknown, lot: unknown, quantity: 1).
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Search Alerts/Recalls
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