(b)(4).Products were returned to biomet uk ltd for evaluation and investigation details are as follows: visual checks: on receiving the ¿hiploc plate¿ and ¿hiploc lag screw¿ a visual check was performed with the following observations found:- hiploc plate various scratches and marking from handling and attempted implantation.Etching is clear.Hiploc lag screw.Various scratches and marking from handling and attempted implantation.Etching is clear.Document review: the below ¿manufacturing history records¿ were reviewed.Mhr - 3918338 std brl 4-holes plate 135 deg 12 devices produced and packaged.12 items were reworked for incomplete is sheet.12 items were then accepted at the completion of manufacturing.Mhr - 2016040531 std brl lag scrw 12.5x125mm.12 devices produced and packaged.No non-conformities scrap or rework.13 complaints have been recorded for a similar issue.The returned hiploc plates have been confirmed as non-conforming.The internal barrel on the hiploc plate has been confirmed as undersize through dimensional checks.The hiploc lag screws in all returned product have been confirmed as conforming to pre-defined specification when manufactured, and require no further action to be taken.A supplier corrective action report, scar- 01951, has been raised on the manufacture to investigate their manufacturing processes in relation to the non-conformance.The risk assessment residual score has increased and will be considered by the product engine management team as part of a health hazard evaluation (b)(4).
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