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Catalog Number 319.006 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Device used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.No service history review can be performed as part number 319.006 with lot number(s) ft00291 is a lot/batch controlled item.The service history review is unconfirmed.Device history records review was conducted.The report indicates that the: dhr review, part number: 319.006, synthes lot number: ft00291, supplier lot number: n/a, release to warehouse date: 21-dec-2016, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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 tips of two depth gauges broke off during surgery on an unknown date.It is unknown the type of surgery and or the exact way the tips broke off.There was no information available about the surgery or patient outcome.It is unknown if the tips were retrieved form the patient or not.Device is available for return.This report involves 2 device.This report is 2 of 2 for (b)(4).
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Manufacturer Narrative
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A product investigation was performed.The following part(s) were returned: 319.006, lot ft00291, mfg 21-dec-2016, qty (b)(4), 319.006, lot 7039736, mfg 28-sep2012, qty (b)(4).The complaint condition is confirmed as the device(s) were received with the proximal portion of the needle broken off at the threads.The distal portion of the needle component was not returned.This is where it connects to the calibrated body of the device.The balance of the device shows surface wear consistent with use which would not impair the function of the device.The complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.The returned depth gauge is used for measuring 2.0mm and 2.4mm screws in various trauma (including veterinary) plating systems.It is listed in techniques guides for the distal radius, distal ulna, elbow system, forefoot/midfoot, distal fibula, distal humerus, clavicle, rotation correction plate system and vet mini fragment system.Based on the date(s) of manufacture the relevant drawings, reflecting the current and manufactured revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The material of the needle component (part # 319.006.3) is (b)(4)), which is an appropriate material for an instrument component of this type.Dimensional inspection is not possible as the needle component was not returned the exact cause of the complaint condition cannot be determined as the handling and use of the device over its lifespan are unknown.However, the condition of the depth gauge is consistent with the result of a bending force applied to the needle portion of the depth gauge that is beyond the yield limit of the material.There is a protection sleeve component to protect the needle during transport and an outer body component which adds additional protection to the needle attachment point during use.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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Service and repair evaluation conducted: the customer reported the tip of the depth gauge broke off.The repair technician reported the gauge tip was broken off and missing and the gauge tip was missing.Tip broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.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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