Internal complaint (b)(4) opened.We don't have any information on how the event occured (shock or not).Based on the reference and lot number of the broken parts communicated by our customer, the dhr confirms that the part has been manufactured according to the specifications.These conclusions are supported by the results obtained following the internal control of defective parts.The first investigation did not permit to conclude for this breakage.Dhr review (raw material, blank parts, semi-finish and finish products) : manufactured according to our specifications.Description of the batch : batch number n°170005 ; lot consumption: (b)(4) parts fully sold to our customer.Analysis of defective parts : conform to internal specification at least for the width of the device.Other remark: additional test ((b)(4)) : the 11th of october 2017, an tensile strength test has been performed on the smallest staple (ref arcad 10-09-09) manufactured by novastep.The parts tested were deliberately out of specifications (leg width out of spec 0.01mm).Result : according to the astm 564, 4 static points bending test was conform; 4 dynamic points bending test was conform.
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Description: two staples (139-15-1414-s, lot numbers 170005 / 180011 ) were implanted on (b)(6) 2019 for a radiolunate fusion.Both staples broke in the patient on (b)(6) 2019.The revision surgery was performed on the patient, on (b)(6) 2019.Both broken staples were returned to extremity medical for analysis.
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