EXACTECH, INC. HUM LNR IMPACT TIP 38M; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number HUM LNR IMPACT TIP 38M |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2023 |
Event Type
malfunction
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Event Description
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As reported, impactor tip snapped in half during impaction of humeral liner.Surgery was a revision of a shoulder spacer to a reverse.Humeral components were being cemented in with humeral liner, humeral tray and stem already assembled.On the initial impaction the stem was still very proud at the time of the first impaction the 38mm impactor tip snapped in half.There were no pieces that fell into patient or wound site.Patient was last known to be in stable condition following the event.Image received.The device is not available for evaluation due to device was stuck in cement so hospital disposed the device.
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Manufacturer Narrative
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Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Manufacturer Narrative
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(h3) based on historical complaint investigations, the image provided, and the reported event, the fractured humeral liner impactor tip reported was likely the result of a stress riser introduced during impaction, which led to crack initiation, propagation, and ultimate fracture.Additionally, the device may have experienced material degradation if sterilized beyond the recommended parameters listed in the reprocessing instruction which could have led to the observed failure.The most probable root cause associated with the reported event of ¿broken / non-functional¿ is associated with a partial or full-thickness crack in the device materials.
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