(b)(4).Additional information was requested, and the following was obtained: please provide procedure date? unknown.Please provide lot number? unknown.Did the needle break at the tip or at the body? at 4mm from the tip.Are there any future interventions; including x-ray planned to locate the broken needle tip and remove it? the surgeon looked for the needle piece with magnets, and then removed the piece with vacuum.What is the most current patient health status and condition? unknown.How was procedure successfully completed? unknown.The needle piece was removed in the first operation.*the site of use was the joint capsule ligament.During suturing on the joint capsule ligament, the surgeon felt that penetration of the needle was poor, but the timing of the breakage was unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name -irgacare, active ingredient(s)- triclosan, dosage form - suture/solid/parenteral, strength - = 2360 g /m.
|