Catalog Number 210820 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Information (3190)
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Event Date 07/17/2017 |
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).Associated medwatch: 1221934-2017-10424, 1221934-2017-10425.
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Event Description
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The affiliate reported via email after implantation of gryphon anchor code 210820 and after stitching the labrum, surgeon realized that sutures get out from the anchor.This was not the first case.In cases before surgeon thought that problem was with patient not following post-operative protocol, but then he realised the same situation with few patients.In this last particular case on (b)(6)2017, surgeon found the problem during the surgery and he decided to make product complaint.Questions wont be answered until the complainant returns from vacation on this date: (b)(6)2017.
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Manufacturer Narrative
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The product was received and inspected visually.The suture card, suture and the pro-knot inserter was returned.However, the br anchor was not available for a physical evaluation.Therefore, we cannot confirm this complaint.No other anomalies were discovered on this device that could've contributed to this failure.Visual inspection of the pro-knot inserter shaft showed signs of use.The inserter handle, suture card and suture seem to be in good condition.The dhr review indicated that this batch of (b)(6) devices were processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Review of the depuy synthes mitek complaints system revealed no other complaints for this lot of (b)(6) devices released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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.Previous evaluation was for the 2nd device that was not returned.Previous medwatch did not have appropriate codes.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Associated medwatch: 1221934-2017-10424, 1221934-2017-10425.
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Manufacturer Narrative
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The product was received and inspected visually.The suture card, suture and the pro-knot inserter was returned.However, the br anchor was not available for a physical evaluation.Therefore, we cannot confirm this complaint.No other anomalies were discovered on this device that could've contributed to this failure.Visual inspection of the pro-knot inserter shaft showed signs of use.The inserter handle, suture card and suture seem to be in good condition.The dhr review indicated that this batch of (b)(4) devices were processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Review of the depuy synthes mitek complaints system revealed no other complaints for this lot of (b)(4) devices released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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.Previous evaluation was for the 2nd device that was not returned.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Associated medwatch: 1221934-2017-10424, 1221934-2017-10425.
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Manufacturer Narrative
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The complaint device is not available for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.Furthermore, the dhr review indicated that this batch of devices were processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Review of the depuy synthes mitek complaints system revealed no other complaints for this lot of (b)(4) devices released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Associated medwatch: 1221934-2017-10424, 1221934-2017-10425.
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Search Alerts/Recalls
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