ZIMMER SWITZERLAND MANUFACTURING GMBH ANN, BLUNT TIP SCREW, 4X46MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
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Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/02/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Ann, proximal humerus, right, long, 8.5x240mm; catalog#47249624008; lot#3026936.Ann, blunt tip screw, 4x40mm; catalog# 47248604040; lot#3068919.Ann, blunt tip screw, 4x44mm; catalog# 472486044-40; lot#3076805.Cortical bone screw, 4x22mm; catalog#47248612240; lot#3068948.Cortical bone screw, 4x22mm; catalog#47248612240; lot#3073758.Cortical bone screw, 4x24mm; catalog#47248612440; lot#3078178.Torque limiting handle; catalog#27923; lot#unknown.Foreign: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00315.0009613350-2022-00317.0009613350-2022-00318.
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Event Description
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It was reported that the surgeon found that 2 of the proximal screws were backed out from the proper position approximately 1 month after the implantation.The surgeon is keeping an eye on the patient's condition and no revision is planned so far.Harm not reported.Attempts have been made and no further information has been made available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.As no product was returned, visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Based on the investigation it could be assumed that further possible contributing factors to the migration of the screw might be multifactorial related to either patient condition, behaviour or implantation procedure.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.The investigation also considered whether the design limitation of the corelock mechanism could be a potential contributing factor.However, further biomechanical testing identified that the product performance is in an acceptable range in comparison with legally marketed similar devices.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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No further event information at the time of this report.
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Search Alerts/Recalls
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