(b)(4).Investigation summary: examination of the returned instrument could not confirm the complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Territory (b)(4) reports that they cannot read sizes on neck trial.Examination of the returned instrument could not confirm the complaint.The size is located on the top of the head of the neck trial and can easily read the size 2 x 3 std.There is some slight discoloration around the etching; however, the size is still readable.Visual analysis found a significant amount of scratching around the neck of the trial.The root cause is attributed to heavy usage.The complaint sample consisted of (1) 201205100 tri-lock bps std neck size 2/3, date code (b)(4).The date code indicates the instrument was manufactured in june of 2008 and is over 10-years old.A search of the complaint database found no prior reports for this product code for this type of allegation.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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