(b)(4).D10: juggerstitch curved implant cat#110024773, lot#65867720.G2: (b)(6).Visual examination of the returned product identified sample one has been cycled one time and both blue anchors remain in the needle; sample 2 has been cycled 2 times and both blue anchors have been deployed from the needle.For the device that has been cycled twice with both anchors deployed (sample 2), it was noted that a blue fiber is present on the pusher wire; however, it cannot be confirmed where the piece originated from.Unable to verify item/lot information as there are no product identifiers on the product and there was no packaging returned with the devices.However, the device that has been cycled 2 times and has the anchors deployed is a curved front-end assembly and the device that has been cycled once and has retained the blue anchors has a straight front-end assembly.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event of the anchor not deploying for part 110024772 is confirmed from product return.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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