AIMING ARM/ RADIOLUCENT
Report
- Report Number
- 8030965-2023-02903
- Event Type
- Malfunction
- Date Received
- March 8, 2023
- Date of Event
- February 20, 2023
- Manufacturer
- SYNTHES GMBH
- Product Code
- JDS
- UDI-DI
- 07612334171108
- PMA / PMN Number
- K201336
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- 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. H10 ADDITIONAL NARRATIVE: A1: PATIENT ID ALSO REPORTED AS G00119783062. D4 H3, H6: PART: 03.043.029. LOT: 2024218. MANUFACTURING SITE: CREATEC GMBH. RELEASE TO WAREHOUSE DATE: 20 JANUARY 2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE AIM-ARM RADIOLUC, P/N: 03.043.029, LOT: 2024218 EXHIBITS SIGNS OF NORMAL USE. NO SIGNIFICANT PRODUCT DEFECT WAS FOUND ON THE SURFACE OF THE DEVICE. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS CONDUCTED. THE AIMING ARM WAS ATTACHED TO THE RETURNED INSERTION HANDLE. AFTER THAT THE LATCH OF THE AIMING ARM WAS SECURED TO THE LATERAL PINS OF THE INSERTION HANDLE. NO SIGNIFICANT PRODUCT PROBLEMS WERE OBSERVED. A FUNCTIONAL TEST TO ASSESS THE ASSEMBLY OF THE AIMING ARM WITH THE NAIL WAS NOT CONDUCTED AS THE LATTER WAS NOT RETURNED FOR EVALUATION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE AIM-ARM RADIOLUC, P/N: 03.043.029, LOT : 2024218 WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. DRAWING/SPECIFICATIONS REVIEWED CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. 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.
PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. ADDITIONAL PRO-CODE: HWC COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.
THIS IS REPORT 1 OF 7 FOR (B)(4).
IT WAS REPORTED THAT ON (B)(6) 2023, WHEN DRILLING FOR SCREW PLACEMENT IN THE PROXIMAL END OF THE ANS TIBIA NAIL, THE MOST DISTAL SCREW (IN THE PROXIMAL SECTION) THE DRILL BIT HIT THE NAIL AND DIDN'T PASS THROUGH THE NAIL. IN ADDITION, THE TNA AIMING ARM DOES NOT APPEAR TO LINE UP WITH THE NAIL PROPERLY. WHEN DRILLING THE PROXIMAL STATIC MEDIAL TO LATERAL SCREW, THE 4.2 DRILL BIT WAS HITTING THE NAIL INSTEAD OF THE HOLE IN THE NAIL. THERE WAS A MILD DELAY IN SURGERY. THE SURGEON DECIDED TO NOT USE THE HOLE THAT THE DRILL BIT WAS MISSING AND MOVED ON TO ANOTHER HOLE IN THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FRAGMENTS WERE GENERATED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT OUTCOME/CONSEQUENCES. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) AIMING ARM/ RADIOLUCENT THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1734958 | AIMING ARM/ RADIOLUCENT | NAIL, FIXATION, BONE | JDS | SYNTHES GMBH | 03.043.029 | 2024218 | 07612334171108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Male | 4.2 3-FLTD DRILL BIT QC/330/100 CALIB| COMPRESSION SCREW/ SHORT| CONNECTING SCREW/ CANNULATED LONG| DRILL SLEEVE / 4.2MM| DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG| INSERTION HANDLE/ RADIOLUCENT LONG| PROTECTION SLEEVE/ 11/8| UNK - NAILS |