The check of the dhr of the lot # involved did not show any pre-existing anomaly on the (b)(4) pieces of tibial positioner manufactured with lot #2015ag08h.This is the first and only complaint received on this lot #.We received the instrument involved and we performed a dimensional check on it: no dimensional anomaly which could have contributed to the event was detected.The involved instrument is provided as alternative to the standard tibial impactor (model # 9065.88.110).Therefore, there is always a back-up instrument present in the operating theatre in case of malfunction of the 9065.88.130.The male and female threads of the involved instrument are functional.The disengagement of the instrument from the tibial plate is performed by rotating the red dial counterclockwise.It is unknown how the instrument was used during surgery, but the surgeon may have experienced some difficulties because of possible high strength applied when tightening the instrument, and then glove slipping on the dial when unscrewing the instrument.Hence, external factors could have caused the freezing of the instrument with the implant.The analysis performed on the instrument did not reveal any anomaly which could have contributed to the event.According to limacorporate post-market surveillance data, this is the first and only complaint received on the product code #9065.88.130 on a total of (b)(4) physica tibial positioner/aligner manufactured since 2014.This event was probably caused by external factors which are not product related.Limacorporate will continue monitoring the market to detect the possible recurrence of this issue.
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