The reported magnum punch, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and customers complaint cannot be confirmed.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: (1) excessive force.Or (2) normal wear and tear.The reported magnum punch is subjected to tapping.Excessive force applied to the instrument can result in instrument failure or damage to the instrument.The magnum punch is also a reusable instrument therefore normal wear and tear can be expected.The instruction for use (ifu) were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Additional information provided in event & device manufacture date.
|