MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 50; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 199721650 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Additional device product codes: kwp;kwq;mnh;mni;osh.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.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 during and unknown procedure on (b)(6) 2019, when closing expedium screw internal thread spliced from lower part of device.This led to tilting of the screw.Surgeon tried twice to close screw properly, but was not successful.Surgery completed with new device.There was surgical "dealy" of thirty (30) minutes.There was no patient harm reported.There were no fragments generated.The procedure was successfully completed.This complaint involves three (3) devices.This is report 1 of 3 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.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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Product complaint # (b)(4).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.Visual examination of the returned screw still had its tabs attached.There was no visible damage on the exterior of the device.The damage was isolated to two thread forms of the screw head, just distal of where the tabs would break off the screw head.The threads were torn rendering the device inoperable.The screw shank also appears to be functionally jammed as it no longer has its polyaxiality.A manufacturing related potential cause was not suspected, therefore, no manufacturing record evaluation is required.The overall complaint was confirmed for the received 5.5 exp verse screw 6.0 x 50 as internal threads of the screw head were torn.Although no definitive root-cause can be determined its possible the threads of the head cross-threaded with the correction key upon tightening.Unintended forces may have occurred during the tightening which tightened the cap causing the screw to jam and loose its polyaxiality.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.
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