BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE 188MM

    MDR report key: 10994470 · Received December 12, 2020

    Report

    Report Number
    8030965-2020-09628
    Event Type
    Injury
    Date Received
    December 12, 2020
    Date of Event
    November 16, 2020
    Report Date
    November 16, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07611819760905
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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: H3, H4, H6: DEVICE HISTORY LOT PART: 03.010.063. LOT: 8326173. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: 04.APR.2013. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H6: INVESTIGATION SUMMARY: INVESTIGATION SITE: CQ ZUCHWIL. SELECTED FLOW: 2. DEVICE INTERACTION/FUNCTIONAL. 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 NAILS (DEMO - NAILS, TWO DIFFERENT LENGTH OF NAIL) AND INSERTION HANDLE (03.019.006) WERE AVAILABLE TO REPRODUCE THE COMPLAINED ISSUE. THE COMPLAINED MALFUNCTION OF "DURING THE DISTAL SCREW INSERTION, THE DRILL BIT SLIGHTLY 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 THESE INSTRUMENTS ARE FULLY FUNCTIONAL. 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. THE USED INSERTION HANDLE (03.019.006) WAS NOT RETURNED TOGETHER WITH THE OTHER INSTRUMENTS, THEREFORE THE ROOT CAUSE OF THE COMPLAINED MALFUNCTION CANNOT BE DEFINED AS IT WAS NOT POSSIBLE TO REPLICATE THE OCCURRENCE WITH THE RECEIVED INSTRUMENTS. 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 AIMING ARM / INSERTION HANDLE / PROTECT SLEEVE. IN THIS RELATION WE WOULD LIKE TO MENTION FOLLOWING IMPORTANT STATEMENT OF THE MULTILOC HUMERAL NAILING SYSTEM. THE PROXIMAL END OF THE NAIL MUST BE INSERTED BELOW THE HUMERAL HEAD SURFACE TO AVOID IMPINGEMENT. THE NAIL LENGTH CAN BE EXTENDED WITH AN END CAP. DO NOT HAMMER, AS THIS MAY INCREASE THE RISK OF IATROGENIC FRACTURES. NOTES: IF NAIL INSERTION IS DIFFICULT, CHOOSE A SMALLER DIAMETER NAIL OR REAM THE INTRAMEDULLARY CANAL TO A LARGER DIAMETER. PRESSURE AGAINST THE ELBOW WHEN ADVANCING THE NAIL PREVENTS DISTRACTION AND POTENTIAL HEALING PROBLEMS. 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. 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 · 1

    (B)(4). THE DEVICE HAS BEEN 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 THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR PROXIMAL HUMERUS FRACTURE WITH THE MULTILOC HUMERAL NAILING (MHN) SYSTEM. DURING THE DISTAL SCREW INSERTION, THE DRILL BIT SLIGHTLY INTERFERED WITH THE NAIL AND THE SURGEON HAD DIFFICULTY IN PASSING THE DEPTH GAUGE THROUGH THE DEVICES, BUT HE COULD CONTINUE THE SURGERY AND CLOSE THE INCISION. JUST AFTER THE SURGERY, THE SURGEON CONFIRMED BY X-RAYS THAT THE DISTAL TWO (2) SCREWS WERE NOT PASSED THROUGH THE NAIL. THE SCREWS WERE INSERTED AT POSTERIOR POSITION. THE SURGEON REMOVED THE SCREWS AND TRIED TO RE-INSERT THE SCREWS AGAIN. THE MOST DISTAL SCREW COULD BE INSERTED SUCCESSFULLY, BUT THE OTHER SCREW COULD NOT BE INSERTED BECAUSE THE BONE STATUS WAS BAD DUE TO REPEATED DRILLING AND SCREW INSERTION. FINALLY, ONE (1) SCREW WERE INSERTED AT DISTAL HOLE AND THE SURGEON GAVE UP INSERTING THE OTHER SCREW AND THE SURGERY WAS COMPLETED WITH FORTY (40) MINUTES DELAY. THE SURGEON COMMENTED THAT THE NAIL IS THICK AND OCCUPIED LARGE SPACE AND THE DISTAL SCREW WAS FIXED FIRMLY. SURGEON COMMENTED THAT THE INSERTION INSTRUMENTS (AIMING ARM, CONNECTING SCREW AND SO ON) HAD SOME PROBLEM AND IT CAUSED THE ABOVE EVENT. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: AIM-ARM LAT F/MULTILOC PHN (PART # 03.019.008, LOT # 8952531, QUANTITY 1); CONNECSCR CANN F/ML HUM NAIL (PART # 03.019.007, LOT # 8535585, QUANTITY 1); PROTECT SLEEVE 12/8 L188 (PART # 03.010.063, LOT # 8033772, QUANTITY 1); DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/03.0 (PART # 03.010.060, LOT # L469611, QUANTITY 1); DRILLSL 8/3.2 F/03.010.063 (PART # 03.010.064, LOT # 8368829, QUANTITY 1); CONSCR F/ML HUM NAIL SYST (PART # 03.019.030, LOT # 8533780, QUANTITY 1); DRILLSL 8/3.2 F/03.010.063 (PART # 03.010.064, LOT # 8591613, QUANTITY 1); DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/03.0 (PART # 03.010.060, LOT # L795566, QUANTITY 1); NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2); SCREWDRIVERS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); DEPTH GAUGES (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 12.0MM/8.0MM PROTECTION SLEEVE 188MM THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459637 12.0MM/8.0MM PROTECTION SLEEVE 188MM MISC ORTHO SURGICAL INSTR LXH SYNTHES GMBH 8326173 07611819760905

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention AIM-ARM LAT F/ML PHN| CONNECSCR CANN F/ML HUM NAIL| CONSCR F/ML HUM NAIL SYST| DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/03.0| DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/03.0| DRILLSL 8/3.2 F/03.010.063| DRILLSL 8/3.2 F/03.010.063| PROTECT SLEEVE 12/8 L188| UNK - DEPTH GAUGES| UNK - NAILS| UNK - SCREWDRIVERS| UNK - SCREWS: TRAUMA