This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.The lag screw reamer and two pins were received for evaluation.The dimensions taken were within specification.It was found that the pin is fractured which remains inside the cannulation of the returned reamer.Also both the returned pins are bent into "u" shapes and exhibit scratches.The device history records were reviewed and no deviations or anomalies were identified.This device is used for treatment.The complaint history reviews were conducted for the devices and found no additional complaints for the same lots.Page 15 of the surgical technique (97-2493-002-00 rev 8 natural nail cephalomedullary standard surgtech-vfinal) states ¿caution: both 3.0 mm and 3.2 mm instruments (guide pins, depth gauges, reamers, taps, pin sleeves) are available.The 3.2 mm versions of the instruments can easily be distinguished as they have gold coating on them.The 3.0 mm and 3.2 mm instruments cannot be used interchangeably.Mixing of these instruments can lead to lag screw mis-measurement which could result in patient injury and/or damage to the instruments.¿ a likely root cause is that a 3.2mm pin was used with a reamer designed for a 3.0mm pin.Multiple mdr reports were filed for this event, please see associated reports: 00522-1 and 00520-1.
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