Model Number FJ911R |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch.Report will be submitted.
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Event Description
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It was reported to aesculap inc.That a abc self-locking assistance4.0x14mm (item # fj911r) was used during a procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the silver locking ring did not raise to lock the screw in place when the screw driver was disengaged.It was reported that the threads of a locking assistance tool had broken off inside the locking ring, causing the screw to become stripped.The complaint device has been returned to the manufacturer for evaluation.As a result of this event additional medical intervention was reported.The surgeon had to remove five (5) successfully implanted screws and removed the stripped screw with locking pliers.The adverse event / malfunction is filed under aic reference cc (b)(4).The associated medwatch reports #: 2916714-2022-00108 (b)(4).
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Manufacturer Narrative
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Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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Event Description
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Investigation complete.
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Search Alerts/Recalls
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