BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS

    MDR report key: 9904362 · Received March 31, 2020

    Report

    Report Number
    8030965-2020-02432
    Event Type
    Malfunction
    Date Received
    March 31, 2020
    Date of Event
    February 28, 2020
    Report Date
    March 4, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819865730
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE RECEIVED INSTRUMENTS HAS SHOWN THAT NO SIGNIFICANT TRACES OF USE ARE PRESENT ONLY THE CUTTING EDGES OF THE DRILL BIT ARE WORN. BY THE EVIDENCE THAT THE CUTTING EDGES OF THE DRILL BIT ARE WORN, WE CAN CONCLUDE THAT THE DAMAGE IS A RESULT OF THAT THE DRILL BIT INTERFERED WITH THE NAIL AS REPORTED. FUNCTIONAL TEST: A FUNCTIONAL TEST WITH THE RETURNED INSTRUMENTS WAS PERFORMED. ANOTHER NAIL (DEMO - NAIL) WAS AVAILABLE TO REPRODUCE THE COMPLAINED ISSUE. THE COMPLAINED MALFUNCTION OF "THE DRILL BIT INTERFERED WITH THE NAIL" COULD NOT BE REPLICATED. THE RETURNED INSTRUMENTS PASSED THE FUNCTIONAL TEST SUCCESSFULLY. THE DRILL SLEEVE AND AS WELL THE DRILL BIT MET THE NAIL HOLE AS INTENDED. NO INTERFERING COULD BE DETECTED. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FAILURE IN MATERIAL OR PRODUCTION COULD NOT BE DETECTED. DIMENSIONAL INSPECTION: AS THIS INVESTIGATION IS FOCUSED IN THE FUNCTIONAL ISSUE AND THIS WAS COVERED THROUGH THE FUNCTIONAL TEST PERFORMED. THEREFORE, NO MEASUREMENTS OF THE FEATURES ARE REQUIRED. SUMMARY: THE COMPLAINT IS RATED AS UNCONFIRMED FOR THESE INSTRUMENTS BECAUSE THAT THERE IS NO ALLEGATION AGAINST OF THESE DEVICES. THE RETURNED INSTRUMENTS PASSED THE FUNCTIONAL TEST SUCCESSFULLY. THE DRILL SLEEVE AND AS WELL THE DRILL BIT MET THE NAIL HOLE AS INTENDED. NO INTERFERING COULD BE DETECTED. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. BASED ON OUR INVESTIGATIONS, WE ONLY CAN ASSUME THAT POSSIBLY AN INSUFFICIENT CONNECTION, OR THAT THE MOUNTED CONSTRUCT ENCOUNTERED UNINTENDED TORSIONAL FORCES, SUCH AS EXCESSIVE FORCE APPLICATION DURING INSERTION, WHICH FINALLY CAUSED THE MALPOSITION OF THE INSERT HANDLE / AIMING ARM. IN THIS RELATION WE WOULD LIKE TO MENTION FOLLOWING IMPORTANT STATEMENT OF THE PFNA SURGICAL TECHNIQUE ¿DSEM-TRM-0714-0120-3_LR.¿: - CAREFULLY INSERT THE PFNA MANUALLY USING SLIGHT BIDIRECTIONAL TURNS OF THE INSERTION HANDLE AS FAR AS POSSIBLE INTO THE FEMORAL OPENING. IF THE PFNA CANNOT BE INSERTED, SELECT A SMALLER SIZE PFNA DIAMETER OR REAM THE MEDULLARY CAVITY TO A DIAMETER THAT IS AT LEAST 1 MM LARGER THAN THAT OF THE SELECTED NAIL. - ALWAYS ENSURE THAT THE CONNECTION BETWEEN PFNA, INSERTION HANDLE AND AIMING ARM IS GOOD, OTHERWISE DRILLING FOR DISTAL LOCKING MAY DAMAGE THE PFNA. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.025.040, LOT: L561859, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 28.SEP.2017. 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.

    Description of Event or Problem · 0

    PATIENT'S OUTCOME IS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: CONNECT-SCR-CANN F/PFN+PFNA (PART# 357.029, LOT# 2223477, QUANTITY# 1); INSERT-HANDLE RADIOLUC F/PFNA (PART # 03.010.405, LOT # 7595885, QUANTITY 1),AIM-ARM 125° F/PFNA BLADE (PART # 03.010.406, LOT # 03.010.406, QUANTITY 1), DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/03.0 (PART # 03.010.061, LOT # L810568, QUANTITY 1), DRILLSL 8/4.2 F/03.010.063 (PART # 03.010.065, LOT # L491756, QUANTITY 1), TROCAR Ø4.2 F/03.010.065 (PART # 03.010.070, LOT # L674743, QUANTITY 1), UNK - NAILS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A SURGERY. DURING THE SURGERY, THE DRILL BIT INTERFERED WITH THE NAIL. THE SURGEON DRILLED A PILOT HOLE WITH A K-WIRE, AND HE COULD DRILL AND INSERT A SCREW. THE SURGEON DIDN'T KNOW CONCRETE MALFUNCTION OF THE DEVICES. IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. THE SURGICAL DELAY WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: CONNECT-SCR-CANN F/PFN+PFNA (PART# 357.029, LOT# 2223477, QUANTITY#. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 3 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369247 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH L561859 07611819865730

    Patients

    Seq Age Sex Outcome Treatment
    1 AIM-ARM 125° F/PFNA BLADE| AIM-ARM 125° F/PFNA BLADE| CONNECT-SCR-CANN F/PFN+PFNA| CONNECT-SCR-CANN F/PFN+PFNA| DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/03.0| DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/03.0| DRILLSL 8/4.2 F/03.010.063| DRILLSL 8/4.2 F/03.010.063| INSERT-HANDLE RADIOLUC F/PFNA| INSERT-HANDLE RADIOLUC F/PFNA| PROTECT SLEEVE 11/8 L188| TROCAR Ø4.2 F/03.010.065| TROCAR Ø4.2 F/03.010.065| UNK - NAILS| UNK - NAILS