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Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00271, 0001032347-2020-00272.Medical products: 1.5mm system twist drill with j notch 1.1 x 50mm, 9mm stop, part# 01-7146, lot# ni.Lactosorb system 1.5mm adjustable self-drilling tap, part# 915-1595, lot# ni.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source - (b)(6).
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Event Description
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It was reported the drill and tap fractured during surgery.The procedure was completed using an alternative drill and tap.No adverse events have been reported as a result of the malfunction.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint is confirmed.The device was returned for investigation.Visual evaluation showed it was fractured near the neck, at the start of the fluted section.The non-conformance database was reviewed for the tap; no non-conformances were found.This is the only complaint for this item# 915-1595, vendor lot# 532852.The most likely underlying cause of the complaint is that excessive force was applied, in excess of what the instrument was designed to encounter.It is possible that the instrument was used over the maximum recommended speed, it was used to tap into high density bone, excessive normal force was applied during tapping, or off-axis forces were applied during tapping.There are no indications of manufacturing defects.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D11 ¿ medical products.1.5mm system twist drill with j notch 1.1 x 50mm, 9mm stop, part# 01-7146, possible lot numbers# 255860, 061220, 394390, 394370, 623130, 623100, 894590, 894520, 894500, 894450, 894250, 714360, and 229520.Lactosorb system 1.5mm adjustable self-drilling tap, part# 915-1595, lot# 532852.
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