Catalog Number 08.501.001.05S |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device broke during insertion; device was not implanted/explanted.Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: july 26, 2016.Expiry date: july 26, 2021.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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It was reported that a surgeon was using a sternal zipfix with needle sterile at the facility.One zip fix failed to tighten on one and broke after cutting on another.The surgeon was still able to use the one that failed to tightened by using a clip on the sternal zipfix so it would not un-tighten and this remains in the patient.The surgeon finished the procedure with back-up devices that were readily available.There was no surgical time delay and no medical or surgical intervention.The surgery was successfully completed.The patient status outcome is unknown.Concomitant devices reported: application instrument (part unknown, lot unknown, quantity 1); cable cutter (part unknown, lot unknown, quantity 1).This is report 1 of 2 for com-(b)(4).
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Manufacturer Narrative
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Initially reported there was no surgical delay.Correction: there was a five to ten minute surgical delay.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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It was reported that there was a surgical time delay of five to ten minutes.No unanticipated x-rays were taken.
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Manufacturer Narrative
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Additional narrative: a product investigation was completed: the returned implant was examined and the complaint condition could not be replicated although damage along the edge is consistent with a sudden break and not a clean cut.The segment that would contain the needle was not returned nor was zipfix that would not tighten (was left in patient as indicated in the description).The specific details regarding the application of force and method of use are unknown; therefore, no definitive root cause was able to be identified.However, returned condition is consistent with implant failure as the result of the application of excessive forces prior to tensioning of the implant.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, functional test and drawing review were performed as part of this investigation.This complaint is confirmed.Per the technique guide, the sternal zipfix system is indicated for primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.Five (5) zipfix implants are recommended for a full midline sternotomy when no other plates are used for fixation.Relevant drawings for the device were reviewed (current and manufactured to revision.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned devices¿ lot numbers and no material review reports, non-conformance reports or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.The specific details regarding the application of force and method of use are unknown; therefore, no definitive root cause was able to be identified.However, returned condition is consistent with implant failure as the result of the application of excessive forces prior to tensioning of the implant.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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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It was clarified that the sternal zipfix with needle that broke, broke after tightening and before the surgeon was able to cut it.It was removed and no other device as implanted.
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Search Alerts/Recalls
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