MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 7X40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 186731740 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2023 |
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product codes: mnh,mni,kwp and kwq.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a (b)(6).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 taiwan as follows: it was reported (b)(6) 2023, that the head fell off halfway through the lock, and the sleeve held the nail head and fell off (the sleeve is still moving).Change new product.Yes, there was patient involvement.The operation went well, no adverse reaction.There were no patient outcome or consequences this report is for one (1) 5.5 ti cort fix 7x40mm.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.D9: device returned.H4: manufacture date added.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 a fragments of the flex ball of the 5.5 ti cort fix 7x40mm was found broken, on consequence of the broken condition the device have an undesired movement.The reported condition can be confirmed.The broken fragments was not returned.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A functional test was unable to be performed since it was not applicable to the complaint condition.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the 5.5 ti cort fix 7x40mm [186731740/353318] would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review (dhr): a manufacturing record evaluation was performed for the finished device product code#:186731740.Lot #: 353318.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 27/09/2022.Manufacturing site: jabil le locle.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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