CORAIL

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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H3, H6: 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. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE OVERALL DEVICE SURFACE WITH SIGNS OF USAGE. ADDITIONALLY, IMPACTION MARKS WERE IDENTIFIED BELOW THE HEAD OF THE DEVICE, LEAVING DEFORMATIONS ON ITS SURFACE. NO OTHER COSMETIC ANOMALY WAS IDENTIFIED. POTENTIAL CAUSE FOR THE IMPACTION MARKS OBSERVED CAN BE ATTRIBUTED TO UNINTENDED USE ERROR BY IMPROPER HANDLING/CARE OF THE DEVICE THAT OVERLOAD THE DEVICE MATERIAL; OR BY IMPACTING THE DEVICE IN UNINTENDED PLACES. PROPERLY HANDLING AND¿ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS PERFORMED USING A BROACH (201203020) AS A DEPUY SYNTHES SAMPLE/MATING COMPONENT. TEST REVEALED THE LEVER LOOSE (BEFORE USAGE) AND UNDESIRED TOGGLE ON THE ASSEMBLY OF THE DEVICE WITH ITS MATING COMPONENT, CONFIRMING THAT THE DEVICE WILL NOT HOLD/RETAIN AS INTENDED. POTENTIAL CAUSE CAN BE TRACED TO A COMPONENT FAILURE LED BY IMPACTIONS ON UNINTENDED PLACES; OR BY EXCESSIVE FORCE APPLIED WHILE TRIALING. PROPERLY HANDLING AND¿ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE CORAIL BROACH HANDLE WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, 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 DEPUY SYNTHES 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.

Description of Event or Problem

IT WAS REPORTED THAT THE CORAIL BROACH HANDLE WAS VERY LOOSE WHEN HOLDING THE MODULAR BOX OSTEOTOME, THOUGH IT HELD BROACHES ADEQUATELY. THE EVENT OCCURRED INTRA-OPERATIVELY, WITH NO PATIENT INVOLVEMENT OR CLINICAL CONSEQUENCES.