Catalog Number 89-8507-400-00 |
Device Problems
Mechanical Jam (2983); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 10/08/2018 |
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 universal modular electric/battery double trigger handpiece, part number 89-8507-400-00, serial number (b)(4) was blocked and not functional.During the partial hip replacement surgery, a delay of 47 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.A different handpiece was used to complete the surgery.There was no additional harm or injury to the patient reported.
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Event Description
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It was reported that the universal modular electric/battery double trigger handpiece, part number 89-8507-400-00, serial number (b)(6) was blocked and not functional.During the partial hip replacement surgery, a delay of 47 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.A different handpiece 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 modular electric/battery double trigger handpiece, part number 89-8507-400-00, 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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Search Alerts/Recalls
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