It was reported that during a femur biopsy procedure, the quick connect hub had allegedly started to wobble and lost the rpm's about fifteen seconds into drilling.It was further reported that another two sleeves were opened, and both had the same issue after about the same amount of drilling.The procedure was completed by using another device.There was no reported patient injury.
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one quick connect hub was received for evaluation.During visual evaluation, it was noted when the device was viewed under the microscope, the proximal uclips were not visible and black residue was noted on the inner side of the quick connect hub.No other visual anomalies were noted to the device.Functional testing was not performed, due to the condition the sample was received.Therefore, the investigation is confirmed for the reported unintended movement issue as the proximal u-clips not visible within the quick connect hub and the investigation is confirmed for the identified device contamination with chemical or other material issue as the black residue was noted in the inner side of the quick connect hub.A definitive root cause for the reported unintended movement issue was due to the proximal u-clip was not visible.Then, definitive root cause for the identified device contamination with chemical or other material issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2024).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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