ZIMMESWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 7X160MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
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Model Number N/A |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3073722.Cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3076755.Blunt tip screw, 4x58mm; catalog#: 47-2486-058-40; lot#: 3054254.Proximal humerus nail cap, 10.5x2.5mm; catalog#: 47-2488-010-02; lot#: 3068978.The manufacturer received x-rays and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00101; 0009613350-2022-00102; 0009613350-2022-00103.
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Event Description
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It was reported that operation was performed with ann nail system.After 4 weeks from the initial, surgeon found three proximal screws were backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.
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Manufacturer Narrative
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Concomitant medical products: cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3073722.Cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3076755.Blunt tip screw, 4x58mm; catalog#: 47-2486-058-40; lot#: 3054254.Proximal humerus nail cap, 10.5x2.5mm; catalog#: 47-2488-010-02; lot#: 3068978.The manufacturer received x-rays and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00101; 0009613350-2022-00102; 0009613350-2022-00103.
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Event Description
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It was reported that operation was performed with ann nail system.After 4 weeks from the initial, surgeon found three proximal screws were backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.
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Event Description
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Investigation has been completed.
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Manufacturer Narrative
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Event description: it was reported that operation was performed with ann nail on (b)(6), 2021.After 4 weeks from the initial, surgeon found three proximal screws were backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.No patient outcome.Review of received data: - no medical reports available - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- x-rays: some x-ray pictures were avaialble for investigation.The x-ray review shows that the proximal screws were backed out.Therefore, the reported event can be confirmed.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.- surgical technique: the applicable surgical technique explains that the locking of the corelock is done using the corelock driver with torque limiting handle.Turn slowly clockwise to tighten and engage the corelock mechanism until a click is felt from the torque limiting handle.- dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that operation was performed with ann nail on (b)(6), 2021.After 4 weeks from the initial, surgeon found three proximal screws were backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.No patient outcome.The quality records show that all specified characteristics have met the specifications valid at the time of production.The received x-rays confirm the reported event, namely that the most proximal screw has migrated.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.An additional deeper investigation was performed which identified the design limitation of the corelock mechanism as a potential contributing factor.However, as further biomechanical testing was carried out and the performance is in an acceptable range in comparison with legally marketed similar devices, no design changes were conducted.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00101-1.0009613350-2022-00102-1.0009613350-2022-00103-1.
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