The complainant reported that when the inserter and implant was being manipulated for placement, one of the handles of the inserter broke from the body of the instrument.The implant had already been placed through the opening prepared in the interspinous space when the malfunction occurred.No further placement or manipulation was required.There were no known patient complications.A visual inspection of the device confirmed the complainant's description of the damage.A dhr review was performed and the device met all required specifications prior to being released to distribution.The inserter malfunction could be replicated if excess force was applied to the handles of the inserter.The inserter ratchet is intended to hold the inserter in a fixed position with the implant loaded.If the handles are compressed further than the implant and ratchet allow, the handle of the inserter may break.
|