SPOTLIGHT ACCESS SYSTEM ILLUMINATED ANATOMIC PORT 15 X 60MM

Description of Event or Problem

DEVICE REPORT FROM THE UNITED ARAB EMIRATES REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SPOTLIGHT SYSTEM PORT FAILED DURING LAMINECTOMY SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A SPOTLIGHT ACCESS SYSTEM ILLUMINATED ANATOMIC PORT 15 X 60MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR SPOT 15X60 ANATOMIC PORT, WAS CONDUCTED IDENTIFYING THAT LOT NUMBER PO34108 WAS RELEASED IN TWO BATCHES. BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON JUNE 07,2021 WITH NO DISCREPANCIES. BATCH2: LOT QTY OF (B)(4) UNITS WERE RELEASED ON JULY 01,2021 WITH NO DISCREPANCIES. SUPPLIER: (B)(4). AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT DISTAL END IS LOOSE AND ROTATES; POTENTIAL CAUSE OF THIS CONDITION CAN BE TRACED TO A COMPONENT FAILURE THAT WAS CAUSED BY EXPOSURE TO UNINTENDED FORCES. SCRATCHES AND DAMAGE IS ALSO OBSERVED ALL OVER THE SURFACE, INCLUDING AT SPOTLIGHT CONNECTION: THIS TYPE OF DAMAGE IS CONSISTENT WITH OTHER TOOLS AND HARD EDGES COMING IN CONTACT WITH THE DEVICE. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. EVEN THOUGH A FUNCTIONAL TEST CANNOT BE FULLY PERFORM WITHOUT MATING COMPONENT, IT IS NOT UNREASONABLE THAT THIS CONDITION OF THE DEVICE CAN LEAD TO A FUNCTIONAL FAILURE, THEREFORE IT IS POSSIBLE TO CONFIRM THE REPORTED ISSUE. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE CONDITION OF THE COMPLAINT. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SPOT 15X60 ANATOMIC PORT WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.