(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not returned for evaluation.
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The surgeon was using the confidence needle 11 x 6g, to locate the tear drop for iliac screw placement.Prior to using this, we had used 2 pieces for the needles, which bent.Upon locating the right placement, the inner trocher was removed, and a viper guide wire was placed in.While removing the wire the surgeon faced some resistance.Upon removing the needle, we found out that part of the needle had broken.We had taken i/i image to confirm this, and the broken part measuring about 5cm looks embedded to the bone.The surgeon tried to remove the broken part but failed.Decision was made to leave it.
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