MODULAR T-HANDLE
Report
- Report Number
- 1526439-2024-03000
- Event Type
- Malfunction
- Date Received
- December 17, 2024
- Date of Event
- December 4, 2024
- Manufacturer
- MEDOS INTERNATIONAL SÃ RL CH
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H6 PHOTO INVESTIGATION: THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER A PHOTO WAS PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED A FRAGMENT OF THE BLACK HANDLE WAS BROKEN. BROKEN FRAGMENT WAS OBSERVED ON IMAGE. HOWEVER, WITH AVAILABLE INFORMATION A COMPLETE POTENTIAL CAUSE CAN NOT BE DETERMINED. SURGICAL TECHNIQUE CONDUIT CURVED TLIF SYSTEM 112696-190424 WAS REVIEWED AND THE FOLLOWING RELEVANT STATEMENT WAS FOUND AT PAGE 14: CONTROLLED AND LIGHT HAMMERING ON THE INSERTER MAY BE REQUIRED TO ADVANCE THE IMPLANT INTO THE INTERVERTEBRAL DISC SPACE. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE MODULAR T-HANDLE WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. PHYSICAL PRODUCT INVESTIGATION: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND ONE OF THE BLACK HANDPIECES WAS CRACKED AND BROKEN. BROKEN FRAGMENT WAS RETURNED FOR ANALYSIS. THE UPPER SURFACE OF THE HANDLE SHOWS EVIDENCE OF HAMMER MARKS. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT WAS CAUSED BY EXPOSURE TO UNINTENDED FORCES. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE MODULAR T-HANDLE WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO A COMPONENT FAILURE, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 A REVIEW OF THE RECEIVING INSPECTION (RI) WAS MODULAR T-HANDLE IDENTIFYING THAT LOT NUMBER WAS TBAHJQ RELEASED IN ONE BATCH. ¿ BATCH 1: LOT QTY 262 OF UNITS WERE RELEASED ON 31 MAY 2023 WITH NO DISCREPANCIES. SUPPLIER; (B)(6). 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. DEVICE HISTORY REVIEW 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H6: THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER A PHOTO WAS PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED A FRAGMENT OF THE BLACK HANDLE WAS BROKEN. BROKEN FRAGMENT WAS OBSERVED ON IMAGE. HOWEVER, WITH AVAILABLE INFORMATION A COMPLETE POTENTIAL CAUSE CAN NOT BE DETERMINED. SURGICAL TECHNIQUE CONDUIT CURVED TLIF SYSTEM 112696-190424 WAS REVIEWED AND THE FOLLOWING RELEVANT STATEMENT WAS FOUND AT PAGE 14: CONTROLLED AND LIGHT HAMMERING ON THE INSERTER MAY BE REQUIRED TO ADVANCE THE IMPLANT INTO THE INTERVERTEBRAL DISC SPACE. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE MODULAR T-HANDLE WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 A REVIEW OF THE RECEIVING INSPECTION OF MODULAR T-HANDLE WAS CONDUCTED IDENTIFYING THAT LOT NUMBER TBAHJQ RELEASED IN ONE BATCH. SUPPLIER : (B)(6). ¿ BATCH1: LOT QTY OF 262 UNITS WERE RELEASED ON 31 MAY 2023 WITH NO DISCREPANCIES. 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. DEVICE HISTORY REVIEW 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT ON (B)(6) 2024 , THE CONDUIT TLIF HANDLE BROKE DOWN AFTER IMPACTING THE CAGE AS SHOWN IN MANUAL. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1457367 | MODULAR T-HANDLE | MISC ORTHO SURGICAL INSTR | LXH | MEDOS INTERNATIONAL SÃ RL CH | TBAHJQ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |