Investigation ¿ evaluation.A review of the device history record, complaint history, quality controls, specification and visual inspection was conducted on the returned device during the investigation.Incomplete device was returned for investigation.It was discovered that only a tether was returned, which was tangled together.During investigation, the tether was untangled and it was observed that the tether was separated into three segments.Two segments had severely stretched appearances indicating that it was pulled by force stressing the material to the point of snapping to separation.Third segment was noted to have the knot intact.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.In addition review of device master record did not observe any nonconformance that may have contributed to this incident.Based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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