ASCENSION ORTHOPEDICS, INC. BASEPLATE/GLENOSPHERE INSERTER; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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Catalog Number INS-0990-861 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2024 |
Event Type
malfunction
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Event Description
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It was reported that, during shoulder replacement surgery, while inserting/impacting the baseplate, the threaded portion of the baseplate glenosphere inserter broke off.The surgery was completed, without any delay, changing the surgical technique.No injuries were reported.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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B5, event description: updated.
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Event Description
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It was reported that, during shoulder replacement surgery, while inserting/impacting the baseplate, the threaded portion of the baseplate/glenosphere inserter broke off.The surgery was completed, without any delay, with the same reported device.No pieces fell into the patient's wound.No injuries were reported.
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Manufacturer Narrative
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H6: the device was not returned for evaluation; therefore, a device analysis could not be performed.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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