ASCENSION ORTHOPEDICS, INC. GLENOID INSERTER TIP S; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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Catalog Number INS-0990-830-01 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Event Description
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It was reported that, during an anatomic shoulder arthroplasty, the tip of one (1) glenoid inserter tip s broke upon insertion of the prothesis.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not harmed as a consequence of this problem.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that, during an anatomic shoulder arthroplasty, the tip of one (1) glenoid inserter tip s broke upon insertion of the prothesis.No pieces fell into the patient.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not harmed as a consequence of this problem.
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Manufacturer Narrative
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H6: the associated device was returned and evaluated.The visual inspection revealed that one tip on the device was fractured off.Overall, the instrument had minimal signs of wear.Evaluation of the device suggests that the tip may have broken off from excessive force.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 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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