Catalog Number 228143 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
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Event Date 08/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Depuy synthes has been informed the lot number is not available.Associated medwatch: 1221934-2017-10526, 1221934-2017-10527, 1221934-2017-10528.
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Event Description
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The affiliate reported via email that during a meniscal repair after the first patch has been placed the second patch could not be loaded.The customer is suspecting a defect in the handpiece.The procedure was completed with a same like product and there was a five minute delay.There was no adverse patient event reported.
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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.Evaluation statement: the complaint devices are not being returned, therefore unavailable for a physical evaluation.No lot numbers were provided which precludes conducting a dhr review or a lot specific search in the complaints handling system.We cannot discern a root cause for the reported failure mode, however one possible root cause is that the meniscus was not penetrated enough when attempting to deploy the second implant.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.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device was received and evaluated.Visual inspection of the device revealed no immediate issues.The deployment rod tip had some procedural debris.Both deployment rod and pusher rod were tested for functionality and were working as intended.No issues could be identified with this device.The root cause could not be determined as there are no clear indications of functional issues with the deployment gun.We cannot confirm this complaint with this device.Review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.A review into the depuy 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.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.Device history lot: dhr review.Part number: (b)(4).Lot number: l436504.Supplier lot number: n/a.Manufacturing date: 13.06.2017.Expiration date: 31.03.2020.Supplier: n/a.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Device history batch: null.Device history review: null.Udi: (b)(4).
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Event Description
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The affiliate reported via email that during a meniscal repair after the first patch has been placed the second patch could not be loaded.The customer is suspecting a defect in the handpiece.The procedure was completed with a same like product and there was a five minute delay.There was no adverse patient event reported.
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Search Alerts/Recalls
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