MEDOS INTERNATIONAL SÃ RL TRUESPAN MENISCAL REPAI SYSTEM PEEK 12 DEGREE; SOFT-TISSUE ANCHOR, BIO-ABSORBABLE
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Catalog Number 228151 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/07/2018 |
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.(b)(4).The expiration date is not currently available.Associated medwatches: 1221934-2018-50411, 1221934-2018-50412.
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Event Description
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It was reported, that in two cases, the second implant fell out spontaneously from the needle without force being applied to the system.The seam had to be redone.In another case, the implants were triggered correctly, but the string could not be tightened reasonably.It is unknown if there were any patient consequences.The following information was obtained from the sales rep on (b)(6) 2018 via e-mail: i was in the hospital for another operation and these mentioned issues were reported to me from an or nurse in the corridor.So i did not support the operation where these issues happened and i only mentioned in the complaint what the or nurse told me.Therefore, unfortunately, i can neither provide you with more detailed information.Nor did the hospital store the truespan devices that caused these problems.These failures happened for three truespan different procedures for the same patient.There was only one patient involved.By different ¿cases¿ i meant the following two different types of failure that occurred: first issue (¿case¿): during the first two truespan procedures, the second implant was fallen out automatically.Second issue (¿case¿): during the third truespan procedure, the string could not be tightened reasonably.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A device history record 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; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.We cannot discern a root cause for the reported failure mode.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 medwatches: 1221934-2018-50411, 1221934-2018-50412.
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Search Alerts/Recalls
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