CURVED LATERAL OSTEOTOME 17

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE CVD LATERAL BLADE TIP GOUGED AND CHIPPED DURING SURGERY. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE DISTAL PART OF THE CURVED LATERAL OSTEOTOME 17 SHOWS CHIPPED AND DEFORMED EDGES. NO SCRATCHES WERE OBSERVED. NO OTHER ANOMALIES WERE IDENTIFIED. THE OBSERVED DEVICE CONDITION IS CONSISTENT WITH EXPOSURE TO HEAVY IMPACTION FORCES WHILE THE CURVED LATERAL OSTEOTOME 17 IS MISALIGNED OFF-AXIS WHEN INSERTION. THEREFORE, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USE ERROR. AS PER "WATSON EXTRACTION SYSTEM SURGICAL TECHNIQUE", PAGE 5; APPLY SLIGHT LATERAL PRESSURE TO THE HANDLE AS YOU CONTINUE STRIKING WITH THE MALLET. THE BLADE WILL FOLLOW THE LATERAL CURVATURE OF THE STEM ENSURING MINIMAL PRESSURE ON THE GREATER TROCHANTER. THE CLAT BLADE WILL BOTTOM OUT ON THE PROXIMAL STEM ENSURING THE TIP OF THE BLADE HAS EXTENDED PAST THE PROXIMAL COATING OF THE STEM. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CURVED LATERAL OSTEOTOME 17 WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USE ERROR, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. H11 ADDITIONAL NARRATIVES." CORRECTED: H3.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT THE CVD LATERAL BLADE TIP GOUGED AND CHIPPED DURING SURGERY.