Evidence of extensive reuse of device.Device subject to unauthorized disassembly and modification, possibly weakening spring and leading to fracture of part.Hardness of fractured material tested and found conforming to specs.Device history record found conforming.Harm to patient not possible, since handle part of device outside surgical field during clinical use.Breakage of spring during surgery would affect ease of use by surgeon, not device function itself.Should more information become available, a supplemental report will be filed.
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