Conclusion and justification status for mdr: functional evaluation of (4) of the submitted sigma hp fbt keel punch impactors with the retuned hp fbt keel punches could not replicate the reported mating issue.Although a surgical environment could not be created for testing purposes, the punch impactor mated and disassembled from the keel punch with no restrictions or difficulties.The investigation could not draw any conclusions about the root cause of the complainant's assembly problems; however, the instruments exhibit evidence of normal use and serving which could be a contributing factor.No evidence was found indicating product error was a contributing factor and no corrective action is being pursued.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.
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