Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Released to warehouse: 06-feb-2019.Expiration date: 31-dec-2027.Part number: 281.520s, 135 deg dhs plate-short barrel 2 holes/46mm-sterile.Lot number: h807562 (sterile).Lot quantity 24.This dhr review is for monument operations only: thermal rinse, packaging / labeling, sterilization and release work order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.(b)(4) was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that on (b)(6) 2020 the patient underwent a hardware removal of the dynamic hip system (dhs) from the left femur due to the patient's age.The plate, lag screw, and (2) 4.5 cortex screws were removed without issues.The procedure was successfully completed.There was no surgical delay reported.Patient outcome was unknown.This report is for one (1) 135 deg dhs plate-short barrel 2 holes/46mm-sterile.This is report 2 of 4 for (b)(4).
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