BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE

    MDR report key: 9536153 · Received December 31, 2019

    Report

    Report Number
    8030965-2019-71572
    Event Type
    Injury
    Date Received
    December 31, 2019
    Date of Event
    January 1, 2019
    Report Date
    December 8, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    PMA / PMN Number
    K172872
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. REVIEWING ATTACHED X-RAY, THE COMPLAINT DESCRIPTION CAN BE CONFIRMED, THAT THE FNS ANTIROTATION SCREW IS BACK OUT. WE HAVE FORWARDED THE RECEIVED PART TO THE RESPONSIBLE SUSTAINING CENTER FOR EVALUATION WITH THE FOLLOWING RESULTS: THE ANTI-ROTATING SCREW DID NOT SCREW PROPERLY DURING THE FEMORAL NECK FIXATION SURGERY ACCORDING TO THE COMPLAINT (B)(4) . IN ORDER TO INSERT THE ANTI-ROTATING SCREW, THE SURGICAL TECHNIQUE (DSEM-TRM-0614-0098-3 LR) REQUIRES THE USE OF THE ANGLED GUIDE 03.168.001 (130° ANGLED GUIDE, FOR WIRED GUIDE F3.2 [MM]). THE SURGEON INSERTED THE ANTI-ROTATING SCREW WITHOUT THE AFOREMENTIONED INSTRUMENT AS IS REPORTED IN THE COMPLAINT. IF THE ANTI-ROTATING SCREW IS NOT INSERTED WITH THE CORRECT TOOLS A MISALIGNMENT IS POSSIBLE, WHICH CAN ALSO LEAD TO THE OBSERVED DIFFICULTIES DURING THE SURGERY AND PAIN UNDER LOADING. THE RECEIVED PARTS WERE DAMAGED DURING THE REMOVAL SURGERY (SEE COMPLAINT NUMBER (B)(4)). BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. DEVICE HISTORY LOT NON-STERILE NECK FIX BOLT L100 TAN, PART: 04.168.300 (60123910), LOT: 3L89269, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: APR.05, 2019. THE NON-STERILE ARTICLE IS A PART OF THE STERILE SOLD KIT BELOW. KIT IMPLKIT F/FEM NECK SYST CONSTRUCTL. 100, PART: 04.168.100S, LOT: 4L34633, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: APR.23, 2019, EXPIRY DATE: APR.01, 2029. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES 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.

    Additional Manufacturer Narrative · 0

    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. 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.

    Description of Event or Problem · 0

    CONCOMITANT DEVICES: FNS PLATE (PART# 04.168.000, LOT# 3L60410, QUANTITY 1), LOCKING SCREW (PART# 412.219S, LOT# 3L40502, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT HAD A FEMORAL NECK FIXATION SURGERY AS DONE ON (B)(6) 2019 AT (B)(6) HOSPITAL. THE SURGERY DID NOT GO WELL, AND THE ANTI-ROTATION SCREW DID NOT SCREW PROPERLY. THE PATIENT WAS COMPLAINING ABOUT PAINS AFTER THE SURGERY. ON THE (B)(6) 2019, IT WAS DISCOVERED THAT THE VARUS COLLAPSE AND IMPLANT PROTRUSION INTO THE FEMUR HEAD. THE IMPLANT IS TOO PROXIMAL. THE PATIENT IS SCHEDULE FOR REVISION SURGERY. THERE WAS NO KNOWN DELAY AND PATIENT CONSEQUENCE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329760 BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 3L89269

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention LOCKSCR Ø5 SELF-TAP L50 TAN| LOCKSCR Ø5 SELF-TAP L50 TAN| NECK FIX PLATE 1-HO TAN| NECK FIX PLATE 1-HO TAN