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Catalog Number 310.534 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/14/2023 |
Event Type
malfunction
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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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h6: 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.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2023, the patient underwent orif surgery for tarsal and metatarsal fractures with drill bit, va locking drill guide, t-fusion plate and locking screw.The surgeon used a t-fusion plate for the patient's third lisfranc arthrodesis.The surgeon inserted a locking screw into the proximal screw hole at a fixed angle.The surgeon then inserted and drilled a fixed-angle sleeve into the next hole.During the drill, the surgeon heard some interfering noises and stopped drilling, but immediately resumed.As the drill felt lighter, the surgeon thought it had reached the contralateral cortex, and when he withdrew the drill, the nurse noticed that the drill bit had become shorter.When the surgeon checked the image, it was confirmed that the drill bit was broken and about 1 cm remained in the bone.Since screws are inserted in other holes, and the drill bit was still in the bone, the surgeon judged that there would be no stimulation to the soft tissue after the surgery, and decided to remain it as is.The surgeon then closed the wound without inserting the screw into the hole with the broken tip.Since the broken drill bit remained in the bone, it was judged difficult to remove it.The surgeon commented that there was no problem with fixation because the first and second lisfranc arthrodesis was also performed.In addition, the surgeon thought that the cause of this event was that the drill bit had interfered with something and broken when he felt a strange noise or feel during drilling.The surgery was completed successfully within 30 minutes delay.Patient status outcome is stable.No further information is available.This report is for one (1) drill bit ø2 w/marking l110/85 2flute f/ this is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6 part #: 310.534 lot #: 872p138.Manufacturing site: jabil bettlach.Release to warehouse date: 24, june 2022.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was 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.H10 additional narrative: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the fluted tip of drill bit ø2 w/marking l110/85 2flute f/ was broken.The broken fragment was not returned for evaluation.The allegation of embedded device was not confirmed as not post operative images were provided to assess the condition.Based on the observed condition of the device, he investigation was able to confirm the reported event.No other problem identified.A dimensional inspection was not performed as it is not applicable to the complaint condition.The observed condition of 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 condition of the drill bit ø2 w/marking l110/85 2flute f/ would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed.Se_144674 rev h current and manufactured.Dimensional inspection: n/a.H4, h6 part #: 310.534.Lot #: 872p138.Manufacturing site: jabil bettlach.Release to warehouse date: 24, june 2022.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was 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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Search Alerts/Recalls
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