Model Number N/A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/07/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.The device is reported to be available for evaluation; however, it has not been received by biomet sports medicine to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 3 states, ¿loosening or migration of the implant.¿.
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Event Description
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It was reported that the patient underwent an unknown procedure on (b)(6) 2015.During the procedure the two anchors that were implanted became loose.The sleeve of the anchor was retained by the patient and a different juggerknot was used to complete the procedure.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.
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Manufacturer Narrative
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Examination of returned device found no evidence of product non-conformance.The root cause could not be determined as the two constructs involved in the complaint were not returned.
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Search Alerts/Recalls
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