The complaint description states that the dr inserted the femoral implant by hand and impacted with definitive impactor.The stem did not seat fully.Dr requested the corail slap hammer to remove stem and rebroach the canal.Two x corail slap hammers on consignment at the mater were opened and dr could not get either threaded tip of slap hammer to engage in the stem - he stated they seemed too wide.The devices associated to the complaint were not returned for analysis.The dhr analysis performed on the two corail slap hammers did not reveal any anomalies that could be related to the issue reported on the complaint.A search into the complaints database was performed, no other similar complaint was reported for the affected product codes and lots combinations.The picture of the two corail slap hammers provided were reviewed by supplier and cpd.From the image it was not possible to confirm any wear and tear on the instrument.Due to lack of returned parts, it has not been possible to evaluate this complaint further and the investigation remains inconclusive.Based on the information received and the investigation performed, the root cause of the incident could not be determined.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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