It was reported, during the procedure, metal fragments were found when removing the ribloc u plus primary guides (part number: rbl2210) from the surgical site.This happened two different times during the surgery.After troubleshooting all components, it was determined that the inside of the drill guides may have been nicked by the drill bit; however, at that time, it was not possible to confirm as it was tough to see.It was decided to remove all four (4) rbl2210 guides and replace with new guides.The procedure was completed, and it was reported there was no adverse consequences to the patient and no delay in procedure time.This report is related to report numbers: 3025141-2022-00333, 3025141-2022-00335, and 3025141-2022-00336 for the other primary guides involved in this event.
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The returned ribloc primary guides were examined visually under magnification.All parts appeared clean without any defects or blemishes.Some mill marks could be seen on the inside of the holes, but there were no surface deformities.Functional testing was performed.All returned guides were able to pass pin gages within.001 of nominal values.A few parts would allow pin gages to go through partially and then "catch" partway through.Part diameters were measured using pin gages.All guides had at least one hole.001" out of range.All guides were tested with a demo drill bit and power source.All guides were able to allow the drill bit to pass through without binding or creating metal fragments as the reported event indicated.The slight deviation in tolerance should not effect the orientation of the drill bit in the hole.The drill bit must the inserted past the larger shaft transition in order to be oriented straight in the guide holes.It is also unclear where the chips/metal fragments were coming from as stated in the reported event.Based on the information received and the investigation performed, the root cause could not be determined.
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