Catalog Number 503004268 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/22/2015 |
Event Type
Other
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Manufacturer Narrative
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The manufacturer did not receive the device for review.Where lot numbers were received for the device, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).
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Event Description
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It was reported that a ultos t8 torx driver was used in a surgery on (b)(6) 2015.After using the device to insert 7 of the 3.5 screws, on inserting the 8th screw the tip of the torx driver broke off in the screw head preventing complete insertion of the 8th screw and resulting in the surgeon not being able to get the 2nd of two proximal screws into the t-fusion plate being implanted.The surgery was completed without the insertion of the last screw.Surgery time was extended for an unknown time.
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Manufacturer Narrative
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Dhr review: dhr records were reviewed and found to be conforming.Trend analysis: no trend identified.Compatibility check: the compatibility check could not be performed as only one product was reported to us.The product compatibility check is not relevant for one product only.Review of incoming information: it was reported that the device broke during insertion of the 2nd proximal screw (8th screw of the surgery) of a t-fusion plate.The surgery was completed without the insertion of the last screw.No x-rays or other documents were available.Device analysis: the device analysis could not be performed, as the device was not available for investigation.Inspection plans: parts tested: sampling rate was 5 out of 25.Possible causes for the reported event according to dfmea: instrument breaks due to excessive deterioration of instruments during long term use.Possible as no explanation given how the device was used.Fracture of instrument due to aging of material due to cleaning and sterilization or due to general corrosion or due to corrosion due to raw material combinations.Possible as the device was not returned for investigation and the condition of the product cannot be checked, this point cannot be excluded.Device breaks due to impaction /torque force on instrument during operation.Possible as no explanation given how the device was used.Damaged instruments due to surgeon or operating room staff unfamiliar with implantation technique.Possible as it is not described if the user did follow the surgical technique or not.Instrument breaks or deforms due to damage of instrument through incorrect use.Possible as it is not described how the user did use the device during surgery.Instrument breaks due to off label use.Possible as it can be that there was am off label use.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).
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Event Description
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It has now been reported, that a scrdriver f.8 scrs plt hdl blu was used in a surgery on (b)(6) 2015.
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Search Alerts/Recalls
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