(b)(4).The product relating to the reported event has been returned to biomet (b)(4) ltd for evaluation and investigation.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: a review of the manufacturing history records for the hiploc plate from this event has not reported any abnormalities or deviations.Complaints: 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-(b)(4), has been raised on sanatmetal 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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