Catalog Number 89-8509-435-10 |
Device Problems
Blocked Connection (2888); Protective Measures Problem (3015); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 07/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.
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Event Description
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It was reported that the ao reamer attachment 350 rpm, part number 89-8509-435-10, serial number (b)(4) was blocked and not functional.During the partial hip replacement surgery, a delay of 50 minutes was reported.The patient was under anesthesia.The reason for the delay was due to time needed for the diagnosis of the handpiece and search of the replacement.Another device was used to complete the surgery.There was no additional harm or injury to the patient reported.
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Universal ao reamer attachment 350 rpm, part number 89-8509-435-10, serial number (b)(6) was not returned for complaint investigation.Therefore, the device could not be visually inspected in an effort to confirm the defect.Device history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.A follow-up medwatch will be submitted if the product is returned or if additional information is received.
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Event Description
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It was reported that the universal ao reamer attachment 350 rpm, part number 89-8509-435-10, serial number (b)(6) was blocked and not functional.During the partial hip replacement surgery, a delay of 50 minutes was reported.The patient was under anesthesia.The reason for the delay was due to time needed for the diagnosis of the device and search of the replacement.Another device was used to complete the surgery.There was no additional harm or injury to the patient reported.
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Search Alerts/Recalls
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