Catalog Number 352.040 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 03/20/2023 |
Event Type
Injury
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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.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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 united kingdom as follows: it was reported on (b)(6) 2023, that the ria 2 system was used in the tibia, the surgeon allowed a registrar to handle the system.Unfortunately the reamer head detached from the system and metal shards came off in the patient.Although i stated that the angle should not surpass 10 degrees as there is too much flexion in the drive shaft this wasn¿t listened to, and the surgeon accepted that too much pressure was put on the system in this instance.We then went to use the standard syn ream system, however as i was between theatres the scrub staff hadn¿t noticed that the stryker power tool needed to be adjusted back to the ream setting from the drill setting which led to the wire bending, and bone burning inside of the patient, damaging the syn ream head (8.5) and syn ream flexible shaft.The stryker system 7 power tool was used, which delivers an incorrect torque on the ria 2 system of 17nm rather than the recommended 3.5-6nm.This was not known at the time.The syn ream system was then used before moving back to the ria 2 system.There was surgical delay.The surgery was not successful.The system was not successful so the surgeon washed out the im canal as best as possible without the ria 2.Patient status/ outcome: higher risk of infection not clearing but no official outcome reported yet.Concomitant devices reported: unk - drill bits: trauma (part # unknown, lot # unknown, quantity # unknown) and unk - guide/compression/k-wires: viper (part # unknown, lot # unknown, quantity 1).This report is for one (1) synream flexshaft.This is report 1 of 5 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.Additional narrative: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that synream flexshaft had no signs of issue or malfunction.The reported condition cannot be confirmed as there is no evidence of misuse.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for synream flexshaft.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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