Catalog Number 199721000S |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2023 |
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 device product codes: kwp, kwq, mnh, mni, osh.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E1: initial reporter facility name: (b)(6) hospital.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 japan as follows: it was reported that a plif (posterior lumbar interbody fusion) was performed on (b)(6), 2023.The screws were inserted into l3/l4, rods were placed, and the outer portion of the correction keys were tightened.After that, distraction was performed, and the inner portion of the correction keys were tightened manually.Cages were inserted, compression was applied after loosening the inner portion of the correction keys, and the inner portion of the correction keys were attempted to be tightened.It was found that the correction keys at the left side of l3 got loose and were separating from the rods.The threads of the correction keys broke, and metal fragments were generated when the outer portion of the correction keys were loosened.The surgeon removed the correction keys and the metal fragments, and replaced them with other correction keys.A snapping sound was heard when the inner portion of the replaced correction keys were tightened manually, so the sales rep informed the surgeon that the threads of the screw might be broken.The screws were replaced by the surgeon, and after this the procedure proceeded smoothly.It was confirmed by x-ray that there were no metal fragments left in the patient¿s body.The surgery was completed successfully within 30 minutes¿ delay.The patient outcome was reported to be stable.This report involves one expedium verse spine system correction key.This is report 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4: expiration date added.D9: device retuned.H4: manufacture date added.H3, h4, h6: 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 threads of the 5.5 exp verse di set scr were broken.Fragments were received for evaluation.A dimensional inspection for the 5.5 exp verse di set scr was unable to be performed due to post manufacturing damage.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 5.5 exp verse di set scr 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.Device history review (dhr): a manufacturing record evaluation was performed for the finished device.Product code: 199721000s.Lot number: 365643.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 03/03/2023.Manufacturing site: jabil le locle.Expiry date: 31/01/2028.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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