PSI
Report
- Report Number
- 3010470577-2023-11091
- Event Type
- Injury
- Date Received
- December 7, 2023
- Date of Event
- November 7, 2023
- Report Date
- February 22, 2024
- Manufacturer
- IN2BONES SAS
- Product Code
- OYK
- PMA / PMN Number
- K211883
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE BATCH RECORDS WAS REVIEWED AND FOUND TO BE COMPLIANT. AFTER INVESTIGATION IT SEEMS THAT THE RC2311-09 IS AN ISOLATED INCIDENT TO DATE. NOT RELATED TO THE DEVICE ITSELF. IT'S A SUCCESSION OF HUMAN ERRORS AS FOLLOWS: THE SURGERY FILE HAS BEEN CREATED BY THE SURGEON FOR A LEFT FOOT (REFER TO IMAGE 1 IN ATTACHMENT). THE X-RAY PROVIDED CONCERNS A RIGHT FOOT SIDE AND THE DICOMS INCLUDES BOTH RIGHT AND LEFT SIDE SCAN. REFER TO THE SCREENSHOT OF THE SCANNER IMAGES PROVIDED FOR CASE (B)(4) SHOWING THAT THE SCANS ARE FOR LEFT FOOT (BROWN CASE), EXCEPTING THAT THE NAME OF THE SCAN FILE INDICATES RIGHT FOOT (GREY CASE). (REFER TO IMAGE 2 IN ATTACHMENT). ONEORTHO ENGINEER INFORMED IN2BONES SAS BY EMAIL DATED OF OCTOBER 6TH, 2023, HE NOTICED THAT THE DICOMS RECEIVED ARE ON THE RIGHT SIDE, WHEREAS THE SURGEON REQUESTED A PSI FOR THE LEFT FOOT SIDE. IN2BONES SAS CONFIRMED BY EMAIL DATED OF OCTOBER 6TH, 2023, THAT ACCORDING TO THE DATA DOWNLOADED, IT'S A LEFT FOOT SCAN EXCEPT THAT THE NAME OF THE SCAN FILE INDICATES RIGHT, AND THE SURGEON HAS CORRECTLY COMPLETED THE FIELD IN THE PLATFORM. THE SURGEON HAS APPROVED THE PLANNING ON THE ORTHOPLANIFY PLATEFORM WITH A LEFT ANKLE AND HAS RECEIVED A PRE-PLANNING REPORT AND PLANNING REPORT WHERE THE REPORT HEADER INDICATES "LEFT SIDE FOOT" AND THE XRAY IMAGE IN PAGE 3 INDICATES "R" FOR "RIGHT FOOT" (REFER TO IMAGE 3 IN ATTACHMENT FOR THE PLANNING REPORT APPROVED). A GLOBAL REVIEW OF ALL COMPLAINTS RELATED TO PSI RANGE WAS PERFORMED. THIS INCIDENT IS THE ONLY ONE REPORTED RELATED TO INCORRECT PSI SIDE DUE TO HUMAN ERROR. AS PER SALES DATA UP TO DECEMBER 1ST, 2023, 333 QUANTUM SURGERIES PERFORMED WITH PSI DESIGNED BY ONEORTHO. THE FAILURE RATE IS THUS ESTIMATED TO 0.30% WHICH CORRESPONDS TO " RARE 0,1% <X<1%" PROBABILITY AS PER RISK MANAGEMENT SOP PMR05. SHOULD ANY OTHER INFORMATION ARISE, IN2BONES WILL UPDATE THIS REPORT.
INVESTIGATIONS IN PROGRESS. A COMPLETE AND FINAL MDR REPORT WILL BE SUBMITTED WHEN ALL INVESTIGATIONS WILL BE PERFORMED.
IN2BONES QUANTUM PATIENT SPECIFIC INSTRUMENTATION (PSI) GUIDES FOR TOTAL ANKLE REPLACEMENT (TAR) IS INDICATED AS AN ORTHOPAEDIC INSTRUMENT SYSTEM TO ASSIST IN THE INSTRUMENTATION POSITIONING DEDICATED TO IN2BONES QUANTUM TOTAL ANKLE REPLACEMENT IMPLANTATION. IN2BONES QUANTUM PSI GUIDES ARE COMPATIBLE WITH QUANTUM TIBIAL TRAY, QUANTUM TIBIAL INLAY, AS WELL AS STANDARD AND FLAT-CUT QUANTUM TALAR IMPLANTS. PSI GUIDES ARE INTENDED FOR SINGLE USE ONLY. PSI GUIDES ARE MANUFACTURED IN CORRELATION WITH A PRE-OPERATIVE PLANNING VALIDATED BY THE SURGEON ON THE TAR PLANNING SOFTWARE AND ASSIST IN THE POSITIONING OF THE DEDICATED QUANTUM INSTRUMENTATION WITH WHICH DRILLINGS OR BONE CUTS WILL BE PERFORMED. IN2BONES QUANTUM PSI GUIDES ARE INDICATED FOR PATIENT POPULATION FULFILLING THE QUANTUM TOTAL ANKLE REPLACEMENT INDICATIONS AND FOR WHICH X-RAYS AND CT-SCAN IMAGES ARE AVAILABLE AND COMPLIANT WITH IMAGING PROTOCOL PROVIDED BY IN2BONES. EVENT DESCRIPTION: A SURGERY WAS UPLOADED AS A LEFT SIDE PSI BASED ON THE PROVIDED CT SCANS. IN2BONES, USA PERFORMED A VERIFICATION OF THE CT SCANS AND CONFIRMED THAT BOTH A LEFT AND A RIGHT SIDE SCAN WAS INCLUDED, BUT THERE WERE FILE NAMES NOT CONSISTENT WITH THE CONTENT. X-RAYS WERE PROVIDED FOR A RIGHT SIDE CASE. RECONSTRUCTION AND PLANNING WERE COMPLETED WITH THE LEFT CT USING RIGHT X-RAY ON REFERENCE MATERIALS IN THE SOFTWARE AND ON ALL PRE-PLANNING AND PLANNING REPORTS PROVIDED TO THE SURGEON. THE DISCREPANCY WAS NOT CAUGHT DURING THE DICOM CHECK AND THE SURGEON HAD VALIDATED THE CASE PLAN AS LEFT BLOCKS PRIOR TO PRODUCTION OF THE BLOCKS. THE PATIENT WAS ON THE TABLE WITH THE INCISION CREATED WHEN IT WAS CAUGHT IN THE OR THAT THE INSTRUMENT SET AND IMPLANTS WERE FOR A LEFT, WHILE THE SURGERY WAS FOR A RIGHT. COMPLAINANT: (B)(6). SURGEON: DR. (B)(6). HOSPITAL: (B)(6).
IN2BONES QUANTUM PATIENT SPECIFIC INSTRUMENTATION (PSI) GUIDES FOR TOTAL ANKLE REPLACEMENT (TAR) IS INDICATED AS AN ORTHOPAEDIC INSTRUMENT SYSTEM TO ASSIST IN THE INSTRUMENTATION POSITIONING DEDICATED TO IN2BONES QUANTUM TOTAL ANKLE REPLACEMENT IMPLANTATION. IN2BONES QUANTUM PSI GUIDES ARE COMPATIBLE WITH QUANTUM TIBIAL TRAY, QUANTUM TIBIAL INLAY, AS WELL AS STANDARD AND FLAT-CUT QUANTUM TALAR IMPLANTS. PSI GUIDES ARE INTENDED FOR SINGLE USE ONLY. PSI GUIDES ARE MANUFACTURED IN CORRELATION WITH A PRE-OPERATIVE PLANNING VALIDATED BY THE SURGEON ON THE TAR PLANNING SOFTWARE AND ASSIST IN THE POSITIONING OF THE DEDICATED QUANTUM INSTRUMENTATION WITH WHICH DRILLINGS OR BONE CUTS WILL BE PERFORMED. IN2BONES QUANTUM PSI GUIDES ARE INDICATED FOR PATIENT POPULATION FULFILLING THE QUANTUM TOTAL ANKLE REPLACEMENT INDICATIONS AND FOR WHICH X-RAYS AND CT-SCAN IMAGES ARE AVAILABLE AND COMPLIANT WITH IMAGING PROTOCOL PROVIDED BY IN2BONES EVENT DESCRIPTION: A SURGERY WAS UPLOADED AS A LEFT SIDE PSI BASED ON THE PROVIDED CT SCANS. IN2BONES, USA PERFORMED A VERIFICATION OF THE CT SCANS AND CONFIRMED THAT BOTH A LEFT AND A RIGHT SIDE SCAN WAS INCLUDED, BUT THERE WERE FILE NAMES NOT CONSISTENT WITH THE CONTENT. X-RAYS WERE PROVIDED FOR A RIGHT SIDE CASE. RECONSTRUCTION AND PLANNING WERE COMPLETED WITH THE LEFT CT USING RIGHT X-RAY ON REFERENCE MATERIALS IN THE SOFTWARE AND ON ALL PRE-PLANNING AND PLANNING REPORTS PROVIDED TO THE SURGEON. THE DISCREPANCY WAS NOT CAUGHT DURING THE DICOM CHECK AND THE SURGEON HAD VALIDATED THE CASE PLAN AS LEFT BLOCKS PRIOR TO PRODUCTION OF THE BLOCKS. THE PATIENT WAS ON THE TABLE WITH THE INCISION CREATED WHEN IT WAS CAUGHT IN THE OR THAT THE INSTRUMENT SET AND IMPLANTS WERE FOR A LEFT, WHILE THE SURGERY WAS FOR A RIGHT. COMPLAINANT: JR TANGHAL SURGEON: (B)(6) HOSPITAL: (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758954 | PSI | QUANTUM PSI GUIDES FOR TOTAL ANKLE REPLACEMENT | OYK | IN2BONES SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |