Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 07/16/2018 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Event Description
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It was reported that the tip of an indicator torque wrench broke during insertion.The surgeon attempted to retrieve the tip, but could not and decided to leave it in as he does not believe it will lead to any risks for the patient.There was no delay of surgery or further patient harm.
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Manufacturer Narrative
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The returned torque indicating wrench was evaluated.The tip was confirmed to be fractured.The cause of this event can likely be attributed to over-torquing of the device.The labeling was reviewed and found to contain instructions regarding product use, including a note letting the user know that this device does not provide an audible click when the appropriate torque is achieved; instead the indicating lines align when the proper torque is met.
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Event Description
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It was reported that the tip of an indicator torque wrench broke during insertion.The surgeon attempted to retrieve the tip, but could not and decided to leave it in as he does not believe it will lead to any risks for the patient.There was no delay of surgery or further patient harm.
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Search Alerts/Recalls
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