Genesis malleable rods 1 and 2 were received for evaluation.Rod 1 was received fully separated.The detachment ends of the separated pieces of the rod showed surfaces to be rough and irregular, indicating stress was exerted.The inner core for rod 1 was separated.Further examination by the sustaining engineer manager indicate there was limited blood on the inside of the malleable, which may indicate the breakage noted occurred after explant.Microscopic examination revealed that there appeared to be silver strands missing from the inner core and the coil aspect appears as if it was cut.The sustaining engineer manager also noted that there was a small area near the separation site where the outer overmold may have been reworked, which is an acceptable process during production.Based on examination and testing, and further examination by the sustaining engineering manager, it was confirmed that the inner core of the malleable rod 1 most likely fractured and as a result of the inner core fracture, the outer rod material may have started to fracture noted by the rough and irregular detachment surfaces.It was noted that a non-coloplast malleable was also returned with this file, but the non-coloplast rod was a different diameter.As the limited information received does not provide further details into the event, and based on examination of the returned product, it is unclear when the full separation of the malleable rod 1 may have occurred.The malleable device was replaced with a titan touch inflatable device.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.
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