Manufacturing site evaluation: internal notification number: (b)(4); device reference code fh813b; device name det.Rongeur standard str 3.0/180mm; serial number n/a; batch number 52382814; udi device identifier (b)(4); udi production identifier (b)(4); basic udi-di n/a.Unit of use udi-di 4046964608186 manufacturing date 18.12.2017 failure description - the moveable handle is detached, since the push button is broken off from the locking.Investigation - vigilance investigator carried out the pictorial documentation visually1 and microscopically2.Signs of friction on the handle part which enters to the box lock are found during investigation.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Batch history review - the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause - based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale - the breakage of the push button was most likely caused by an overload situation, probably torsion.It is convincible that the customer thought the push button is a screw and tried to disassemble the push button by unscrew it.Some competitor products are working this way.Therefore, there is the possibility that the customer tried to unscrew the push button and damaged the instrument.Furthermore the signs of friction on the handle part could have been caused by a insufficient lubrication, which in consequence can cause a higher friction when activating the push button.So higher forces are needed.Corrective action - according to sop sa-de13-m-4-2-04-000-0 a capa (corrective and preventive action) is not necessary.
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