Catalog Number 309.065 |
Device Problem
Break (1069)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.Health effect - clinical code appropriate term/code not available ((b)(4)) used to capture bone injury.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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Event Description
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Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021, the patient underwent removal surgery of a femoral neck system (fns) nail and total hip arthroplasty.When the surgeon tried to remove a screw with the screwdriver which is other company¿s product, the screwdriver broke, and the tip of the screwdriver remained in the screw head.The surgeon cut the screw head with a carbide drill and used the hollow reamers to remove the shaft of the screw.The tip of both hollow reamers chipped off when the surgeon was reaming the bone.After excavating the bone with the chipped hollow reamer, the screw was removed by grasping with pliers, and a total hip arthroplasty was performed.The surgery was completed successfully with a 45 minute delay.The adverse health effects caused by this event were as follows: increase in the amount of bleeding associated with prolonged operation time, prolongation of anesthesia time, excessive bone excavation associated with screw removal, and additional use of physiological saline for removal of iron powder associated with excavation.Concomitant device: unknown screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) hollow reamer complete for 6.5mm & 7.0mm screws.This is report 1 of 4 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: a product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that hollow-reamer-compl anticlockwise cuttin the reamer was broken at the tip, and broken piece was not returned no other issues were identified.The dimensional inspection was not performed sue to post manufacturing damage.The observed condition hollow-reamer-compl anticlockwise cuttin in the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed broken condition of the hollow-reamer-compl anticlockwise cuttin.While no definitive root cause could be determined, it is probable that the hollow-reamer-compl anticlockwise cuttin was broken due to the unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part # 309.065 , lot # 9829656, manufacturing site: werk bettlach, release to warehouse date: 18 may2016.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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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Search Alerts/Recalls
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