STRYKER INSTRUMENTS-KALAMAZOO STERNUM BLADE GUARD; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 4107008000 |
Device Problem
Disassembly (1168)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/18/2015 |
Event Type
malfunction
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Event Description
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It was reported during product inspection at the user facility, the customer observed that several pieces of metal were removed from the tip of thad blade guard.The customer was concerned if the metal pieces remain in a patient and the potential to cause damage.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Event Description
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It was reported during product inspection at the user facility, the customer observed that several pieces of metal were removed from the tip of the blade guard.The customer was concerned if the metal pieces remain in a patient and the potential to cause damage.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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The reported event, there is advanced wear on the distal tip of the blade guard, was not confirmed.However, the reported event of metal pieces came off of the device, was confirmed.The technician observed damage to the tip of the device and a small amount of material was missing.Further visual inspection revealed that the leg was bent and damaged.Based on a review of risk documentation and age of the device, improper use including using excessive lateral force during operation can cause or contribute to the reported event.
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Event Description
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It was reported during product inspection at the user facility, the customer observed that several pieces of metal were removed from the tip of the blade guard.The customer was concerned if the metal pieces remain in a patient and the potential to cause damage.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Search Alerts/Recalls
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