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Catalog Number 388.720 |
Device Problems
Difficult to Open or Close (2921); Material Twisted/Bent (2981)
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Patient Problem
No Code Available (3191)
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Event Date 03/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 argentina as follows: it was reported that a patient underwent surgery on (b)(6) 2019 to correct scoliosis.During the surgery, the front grips of the bolt cutter were extremely worn and open so that it was impossible to perform the gripping maneuvers.The cut bar was in bad condition and was not suitable for cutting cobalt chrome bars.There was bending of the cutting edge of the bars which made it impossible to cut with the in-situ bars.When trying to make the final adjustment of the system, the anti-torque of the bolt cutter did not work.The shear did not cut properly, that's why the inners had to be removed to cut the bar outside.When trying to make the final adjustment, due to the wear of the unknown screwdriver it was impossible to reach the end of the adjustment because it rounded the nuts of the system.The final adjustment was attempted, however eight (8) unknown consecutive nuts were rounded (inners were nicked).Procedure was not successfully completed.There was a surgical delay of one (1) hour.Patient outcome is reported as not being able to fully correct the deformity and not able to make the adjustment.This report is for one (1) bolt cutter.This is report 1 of 1 for complaint (b)(4).
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Event Description
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It was further reported that the final adjustment was attempted, and six (6) consecutive nuts were rounded by the bad condition of the nuts but it was also mentioned that eight (8) were damaged and considered unusable since the inners were nicked.The procedure was terminated but the result was not optimal because it was not possible to finish correcting the deformity.From a correction of a curve of 70 degrees that had to be taken to 15 degrees, it was possible to take it up to 40 degrees.
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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.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.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.Both distal cutting jaws on a returned device have a portion of the cutting surface broken off and deform on both sides of the jaws.The fracture patterns are circular suggesting that the device broken while cutting a circular object (bolt).Device was tested for opening and closing functionality and it was determined to function perfectly after 10-15 attempts.Device will not open or close can not be confirmed.An accurate dimensional inspection was not possible due to the post manufacturing damage on tapered surfaces.Document/specification review: rod/cutter design drawing 388_72 revision h was reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.Conclusion: a definitive root cause for the damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Part number: 388.720, lot number: t165145, manufacturing site: tuttlingen, release to warehouse date: 15-may-2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.
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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.Upon receipt of the device, during initial visual inspection, the device was noted to be broken around the blades.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.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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Concomitant devices reported: expedium torque shaft (part #: 279712600, lot #: unknown, quantity: 1), expedium single innie set screw (part #: 179702000, lot #: unknown, quantity: 8).
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