Catalog Number 211042 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/19/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In transit.
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Event Description
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The sales rep reported that during a shoulder procedure the customer's lupine spiral fluted drill bit created a small amount of metal shavings in the patient.The sales rep stated that the surgeon stopped immediately and used a shaver to remove all the metal shavings.The sales rep stated that he believes the device is bent.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep was unable to read the lot number for the device but stated that the device is approximately two years and heavily used in the field.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.The following additional information was received via phone from the sales rep on 09/15/2015: the customer's lupine hybrid fish mouth drill guide (green handle) was used with the drill bit during this procedure.The device will also be returning for evaluation.See associated medwatch # 1221934-2015-00977.
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Manufacturer Narrative
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The complaint device was received and evaluated.Visual observation confirms the laser markings on the device are slightly faded, but there was no damage to the device that would have contributed in the reported failure.The device appears worn indicating heavy use.The reported failure was found to be caused by the damaged guide, and not the drill.A review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Event Description
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The sales rep reported that during a shoulder procedure the customer's lupine spiral fluted drill bit created a small amount of metal shavings in the patient.The sales rep stated that the surgeon stopped immediately and used a shaver to remove all the metal shavings.The sales rep stated that he believes the device is bent.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep was unable to read the lot number for the device but stated that the device is approximately two years and heavily used in the field.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.The following additional information was received via phone from the sales rep on 09-15-15: the customer's lupine hybrid fish mouth drill guide (green handle) was used with the drill bit during this procedure.The device will also be returning for evaluation.See associated medwatch # 1221934-2015-00977.
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Manufacturer Narrative
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The complaint device has not been returned, despite requesting for it several times, therefore unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Event Description
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The sales rep reported that during a shoulder procedure the customer's lupine spiral fluted drill bit created a small amount of metal shavings in the patient.The sales rep stated that the surgeon stopped immediately and used a shaver to remove all the metal shavings.The sales rep stated that he believes the device is bent.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep was unable to read the lot number for the device but stated that the device is approximately two years and heavily used in the field.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.The following additional information was received via phone from the sales rep on 09-15-15: the customer's lupine hybrid fish mouth drill guide (green handle) was used with the drill bit during this procedure.The device will also be returning for evaluation.See associated medwatch # 1221934-2015-00977.
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Search Alerts/Recalls
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