AIMING ARM/ RADIOLUCENT
Report
- Report Number
- 8030965-2025-00985
- Event Type
- Malfunction
- Date Received
- January 29, 2025
- Report Date
- January 29, 2025
- Manufacturer
- SYNTHES GMBH
- Product Code
- JDS
- UDI-DI
- 10886982297396
- PMA / PMN Number
- K201336
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- 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. THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT [03.043.029, AIMING ARM/ RADIOLUCENT] HAS BROKEN. THE OBSERVED CONDITION OF THE DEVICE WAS CONSIST WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCE. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE [AIMING ARM/ RADIOLUCENT] WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE AIMING ARM/ RADIOLUCENT HAS BROKEN BECAUSE OF CAUSE TRACED TO 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 COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPEDICS 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: PART#: 03.043.029, LOT#: 2024219, MANUFACTURING SITE: WERK SELZACH, RELEASE TO WAREHOUSE DATE: 02 FEB2021, SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCE'S WERE IDENTIFIED. 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.
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. H3, H4, H6 PHOTO INVESTIGATION: THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS , HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT [03.043.029, AIMING ARM/ RADIOLUCENT] HAS BROKEN . THE OBSERVED CONDITION OF THE DEVICE WAS CONSIST WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCE. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE [AIMING ARM/ RADIOLUCENT] WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE AIMING ARM/ RADIOLUCENT HAS BROKEN BECAUSE OF CAUSE TRACED TO 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 COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPEDICS 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 REVIEW (DHR): PART # 03.043.029, LOT # 2024219, MANUFACTURING SITE: WERK SELZACH, RELEASE TO WAREHOUSE DATE: 02 FEB2021, SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. H11 ADDITIONAL NARRATIVE: ADDED: A1, B5, H8 CORRECTED: D4 (PRIMARY UDI NUMBER), G1 (MANUFACTURING SITE NAME), H4, H6 (HEALTH EFFECT - CLINICAL CODE, IMPACT CODE) 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. H11 ADDITIONAL NARRATIVE: ADDED: D9, E1 (FACILITY NAME). H3, H4, H6: PHOTO INVESTIGATION: THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT [03.043.029, AIMING ARM/ RADIOLUCENT] HAS BROKEN. THE OBSERVED CONDITION OF THE DEVICE WAS CONSIST WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCE. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE [AIMING ARM/ RADIOLUCENT] WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE AIMING ARM/ RADIOLUCENT HAS BROKEN BECAUSE OF CAUSE TRACED TO 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 COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPEDICS 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 DEVICE INVESTIGATION: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND BOTH TABS OF THE LATCH WERE BROKEN. BROKEN FRAGMENTS WERE RETURNED FOR ANALYSIS AND NO ISSUES WERE IDENTIFIED. THE DEVICE SHOWS SIGNS OF NORMAL USE/WEAR AND NO EVIDENCE OF HAMMER MARKS WERE OBSERVED, THEREFORE, A POTENTIAL CAUSE CANNOT BE ESTABLISHED WITH THE PROVIDED INFORMATION. THE SEMI-EXTENDED PARAPATELLAR APPROACH SURGICAL TECHNIQUE GUIDE WAS REVIEWED. FOLLOWING RELEVANT STATEMENTS WERE FOUND FOR MOUNT OF THE AIMING ARM: CONFIRM THAT THE NAIL IS SECURELY CONNECTED TO THE INSERTION HANDLE, ESPECIALLY AFTER HAMMERING, USING THE SCREWDRIVER. MOUNT THE AIMING ARM TO THE INSERTION HANDLE. ATTACH THE AIMING ARM TO THE INSERTION HANDLE, BY SLIDING IT INTO THE HOOK AT THE DISTAL PART OF THE INSERTION HANDLE AND THEN ROTATING THE LATCH TOWARDS THE INSERTION HANDLE FOR BOTH PARTS TO CONNECT. PRECAUTION: DO NOT EXERT FORCES ON THE AIMING ARM, PROTECTION SLEEVE, DRILL SLEEVES AND DRILL BITS. THESE FORCES MAY PREVENT ACCURATE TARGETING THROUGH PROXIMAL LOCKING HOLES AND DAMAGE THE DRILL BITS. NOTE: THE PROXIMAL AP SCREW IS INSERTED THROUGH THE GUIDING HOLE IN THE INSERTION HANDLE AND DOES NOT REQUIRE AIMING ARM TO BE ATTACHED. ASSEMBLE THE THREE-PART TROCAR ASSEMBLY (PROTECTION SLEEVE, DRILL SLEEVE, AND TROCAR). ALIGN THE TRIANGULAR MARKING AT THE TIP OF THE PROTECTION SLEEVE WITH THE MARKING BESIDE THE DESIRED HOLE ON THE AIMING ARM AND INSERT THE THREE-PART TROCAR ASSEMBLY THROUGH THE AIMING ARM. MAKE A STAB INCISION AND INSERT THE TROCAR TO THE BONE. TWIST THE PROTECTION SLEEVE BY A QUARTER TURN TO LOCK IT INTO PLACE. REMOVE THE TROCAR. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE AIMING ARM/ RADIOLUCENT 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 REVIEW (DHR): PART # 03.043.029 LOT # 2024219 MANUFACTURING SITE: WERK SELZACH RELEASE TO WAREHOUSE DATE: 02 FEB2021 SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 AN UNKNOWN DATE THE INSTRUMENT WAS BROKEN. THE PLASTIC ATTACHMENT PIECES BROKE DURING SURGERY AND A REPLACEMENT INSTRUMENT IS NEEDED.
ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS AN INTRAOPERATIVE EVENT. THERE WAS NO SURGICAL DELAY AND THE PATIENT WAS NOT AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2047322 | AIMING ARM/ RADIOLUCENT | NAIL, FIXATION, BONE | JDS | SYNTHES GMBH | 2024219 | 10886982297396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male |