This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report, to correct information provided in the initial report, and to provide the results of the investigation of the reported event.Correction to b1, b2, and h1: this event is also considered to be an adverse event/serious injury due to the intervention required to remove the "coil".Correction to b4 of initial report: date of this report was 13-apr-2021.The subject device was not returned for evaluation; therefore, a definitive root cause could not be determined.However, a health hazard evaluation (hhe) was performed for the reported failure.The "coil" is a stainless steel spiral guard which is located in the distal end of the device that dislodged from the ptfe teflon sheath.The hhe determined that when the spiral guard has dislodged from the ptfe teflon sheath, it has the potential to damage surrounding tissue, resulting in harm to the patient.For this event, there was no report of patient harm or tissue damage.Although the subject device was not returned, there was an investigation performed on a returned device for a similar complaint.In that investigation, there was no visible damage to the instrument identified that could have led to the failure mode.Additionally, there was no visible damage to the spiral guard itself.The device was then actuated repeatedly to determine if the functionality of the needle was affected and no malfunction was observed.In addition, a total of five (5) ins-5450 devices were subject to a battery of tests in an attempt to recreate the failure mode.Ultimately, the exact failure mode (i.E., the spiral guard becoming dislodged) could not be replicated.Despite not being able to recreate the failure, the investigation did conclude that the receiving inspection criterial for the ins-2450 (i.E., the raw material code for the ins-5450) be revised to include an inspection step to ensure that the spiral guard is located at the specified distance from the end of the ptfe teflon sheath.This supplemental report is being submitted as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.
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