LAMBOTTE OSTEOTOME CVD 1/4

Additional Manufacturer Narrative

THE LAMBOTTE OSTEOTOME CVD 1/4 (250260) WAS NOT RETURNED FOR AN EVALUATION. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD WAS NOT AVAILABLE FOR REVIEW. THERE HAS BEEN NO RETURN OF PRODUCT FOR EVALUATION. NO CONTACT OR CUSTOMER INFORMATION WAS AVAILABLE ON THE FORM. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE ISSUE OF BREAKING MAY BE THE RESULT OF WEAR OR ROUGH HANDLING.

Description of Event or Problem

THE FOLLOWING WAS REPORTED VIA MEDWATCH/MDR REPORT # MW:5188148: "DURING A TOTAL HIP REVISION, WHILE ATTEMPTING TO TAKE OUT LINER USING A 1/4 OSTEOTOME, THE OSTEOTOME BROKEN HALF." IT IS UNKNOWN WHETHER PATIENT INJURY OR SURGICAL DELAY OCCURRED; HOWEVER, IT WAS MENTIONED THAT THE FAILURE REQUIRED AN INTERVENTION, AND THE SPECIFICITY OF THE INTERVENTION WAS NOT MENTIONED. NO INITIAL REPORTER DETAILS WERE PROVIDED; THUS, NO REQUEST FOR ADDITIONAL INFORMATION IS POSSIBLE AT THIS TIME.