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Catalog Number 254660 |
Device Problem
Separation Failure (2547)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/27/2018 |
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.Udi: (b)(4) - incomplete.The expiration date is not currently available.Associated medwatch: 1221934-2018-50703, 1221934-2018-50705, and 1221934-2018-50706.
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Event Description
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It was reported via phone by the sales rep that during an acl procedure, the doctor inserted the intrafix tibial sheath fine, but when he was trying to insert the intrafix peek screw, it would not screw in the bone.The doctor stated the sheath was getting damaged due to the patient's hard bone, and removed the sheath.The doctor attempted to insert another sheath and screw, but the same thing happened.The doctor then re-dilated the hole and using the same size sheath and screw successfully completed the procedure.There were no patient consequences or delays.No replacement devices were sent out, just a trunk adjustment.
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.A review into the mitek complaints system revealed one other dissimilar complaint for this lot of devices.At this point in time, no corrective action is required and no further action is warranted.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.Udi: (b)(4).Associated medwatch: 1221934-2018-50703, 1221934-2018-50705 and 1221934-2018-50706.
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Event Description
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It was reported via phone by the sales rep that during an acl procedure, the doctor inserted the intrafix tibial sheath fine, but when he was trying to insert the intrafix peek screw, it would not screw in the bone.The doctor stated the sheath was getting damaged due to the patient's hard bone, and removed the sheath.The doctor attempted to insert another sheath and screw, but the same thing happened.The doctor then re-dialated the hole and using the same size sheath and screw successfully completed the procedure.There were no patient consequences or delays.No replacement devices were sent out, just a trunk adjustment.
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Search Alerts/Recalls
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