ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, LEFT, 7X160MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
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Model Number N/A |
Device Problems
Mechanical Problem (1384); Migration (4003)
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Patient Problems
Pain (1994); Insufficient Information (4580)
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Event Date 06/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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Medical products: blunt tip screw, 4x40mm; catalog#47-2486-040-40; lot#3010638; blunt tip screw, 4x36mm; catalog#: 47-2486-036-40; lot#: 3024660; blunt tip screw, 4x42mm; catalog#: 47-2486-042-40; lot#: 3010651; cortical bone screw, 4x24mm; catalog#: 47-2486-124-40; lot#: 3039388; cortical bone screw, 4x26mm; catalog#: 47-2486-126-40; lot#: 3010596; proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3046108.Therapy date: unknown.The manufacturer did not receive x-rays or other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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).
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Event Description
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Patient was implanted on an unknown side and two months from the initial surgery it was reported that the first blunt screw had gradually migrated 2cm from the proper position.The torque driver was used to engage the corelock, followed by non-torque driver to tighten it more.A revision surgery has not yet taken place.
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Event Description
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No event update.Investigation results are now available.
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Manufacturer Narrative
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Investigation results were made available.Review of event description: it was reported that the patient received an implant on (b)(6) 2020 and after two months from the initial surgery, #1 blunt screw had gradually migrated 2cm from the proper position.The revision surgery is yet to occur.Review of received data: due diligence: further due diligence to support the conclusion was completed and documented in diligence log.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Surgical technique sap: the surgical technique 197-glbl-en 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.Conclusion: it was reported that the patient received an implant on (b)(6) 2020 and after two months from the initial surgery, #1 blunt screw had gradually migrated 2cm from the proper position.The revision surgery is yet to occur.Neither x-rays, operative notes, office visit notes, nor devices or photos of the devices were received; therefore the condition of the components is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.The locking of the corelock during the initial surgery has not been performed as specified in the surgical technique using only the corelock driver with torque limiting handle.Instead, additionally a non-torque limiting screwdriver was used.It remains unknown what the potential effect of this deviation from the surgical technique could be.Based on the investigation the reported event cannot be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).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, behavior, implantation procedure or design features.If and to what extent any of these aspects may have influenced the backing out of the screw remains unknown.The need for corrective measures is not indicated for the time being and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
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