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Catalog Number 314.467 |
Device Problem
Bent (1059)
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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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Device was used for treatment, not diagnosis.No patient involvement.It is unknown when event occurred.Device is an instrument and is not implanted/explanted a review of the device history records has been completed.Manufacturing location: supplier - (b)(4), packaged by: (b)(4).Manufacturing date: february 08, 2015 part #: 314.467, lot#: 7799892 (non-sterile) - stardrive screwdriver shaft tb 105 mm.Quantity 105.No non-conformance records (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Subject device has been received and is currently in the evaluation process.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 the tip of a stardrive screwdriver that engages the screw head is twisted.This was discovered during a routine set inspection.No patient involvement.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (t8 stardrive screwdriver shaft, part 314.467, lot 7799892).It was reported that the tip of a stardrive screwdriver that engages the screw head is twisted.This was discovered during a routine set inspection.No patient involvement.No additional information available.The t8 stardrive screwdriver shaft (314.467) is a common trauma instrument, noted in 30 system technique guides including: 2.4mm va lcp distal radius, compact distal radius and modular clavicle plate.In each instance the instrument is utilized for screw insertion/removal.The returned instrument was examined and the complaint condition was able to be confirmed as the distal tip of the driver is twisted approximately 15 degrees in the direction of resistance met during screw insertion.No definitive root cause was able to be determined however the failure mode is typically associated with the application of force which exceeded the plastic deformation limit of the screwdriver shaft.Relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision).The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No product design issues or discrepancies were observed.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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