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Model Number 53-27214S |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Information (3190)
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Event Date 03/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device was misplaced by the customer.
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Event Description
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The surgeon reported that when implanting a distal radius plate, two 2.7mm screws were twisting in the hole and not getting purchase.The case was completed using 2 new 2.3mm screws and by drilling 2 new holes along the oblong.The patient was young and with good bone.There was a short delay of a few minutes while additional holes were drilled and new screws were obtained.The surgeon was satisfied with the outcome of the case.
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Manufacturer Narrative
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The reported event that bone screw, t7, 2.7x14mm was alleged of 'device stripped/twisted' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided despite multiple attempts.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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The surgeon reported that when implanting a distal radius plate, two 2.7mm screws were twisting in the hole and not getting purchase.The case was completed using 2 new 2.3mm screws and by drilling 2 new holes along the oblong.The patient was young and with good bone.There was a short delay of a few minutes while additional holes were drilled and new screws were obtained.The surgeon was satisfied with the outcome of the case.
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Search Alerts/Recalls
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