Model Number 9013.75.355 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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By checking the dhr of the lot #20bh01d, no pre-existing anomalies were detected on all the components manufactured with this lot #.This is the first and only complaint received on this lot #.We will submit a final mdr once the investigation will be completed.
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Event Description
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During shoulder surgery performed on (b)(6) 2020, the tip of the smr shaft angled glenoid reamer (product code 9013.75.355, lot# 20bh01d) broke while reaming.According to the complaint source, the instrument was used less than 15 times.Surgery was completed using shaft from another tray.No consequences were reported for the patient.Surgery was delayed of about 35-40 minutes.Event happened in the us.
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Manufacturer Narrative
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By checking the dhr of the lot #20bh01d, no pre-existing anomalies were detected on the total number of instruments manufactured with this lot #.Very few info received about this case: according to the info reported by the complaint source surgeon used the instrument according to the appropriate steps described in the relevant surgical technique.The product code involved in this complaint (9013.75.355 v00, shaft for angled glenoid reamer) was used on the market in controlled release phase.After receiving a total of 8 complaints from the market, technical investigation identified all the potential critical points related to the instrument geometry: a corrective action was put in place to increase the mechanical resistance of the shaft for angled glenoid reamer leading to a new version (01) of the instrument.Moreover, an additional note ("in case of hard/sclerotic glenoid bone surface, the initial glenoid drill can be optionally used to prepare the glenoid seat for reaming") in the relevant surgical technique related to the optional pre-drill step will be added.This is a final report.Limacorporate will continue monitoring the market to promptly detect any further similar issue.
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Event Description
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During a shoulder surgery performed on (b)(6) 2020, the tip of the smr shaft angled glenoid reamer (product code 9013.75.355, lot# 20bh01d) broke while reaming.According to the complaint source, surgery was completed using a shaft from another tray.No consequences were reported for the patient.Surgery was delayed of about 35-40 minutes.Estimated number of uses of the instrument: less than 15 times.Event happened in the us.
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Search Alerts/Recalls
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