BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL

    MDR report key: 6821634 · Received August 25, 2017

    Report

    Report Number
    3003875359-2017-10422
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 26, 2017
    Report Date
    July 26, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HSB
    UDI-DI
    07611819425583
    PMA / PMN Number
    K103002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    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

    CONCOMITANT DEVICES UPDATED. 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

    DHR REVIEW WAS COMPLETED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 18.AUG.2016. 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

    CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICES. 03.019.008 / LOT L041783 / AIM-ARM LAT F/MULTILOC PHN: AS RECEIVED CONDITION OF DEVICE: VISUAL EXAMINATION REVEALED THAT THE AIM-ARM DOES SHOW MARKS OF SLIGHT USE. LABELING AND COLORED SIGNS ARE FULLY READABLE AND ARTICLE WAS DETERMINED AS IN WORKING ORDER. DHR-REVIEW: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE BELOW LISTED ARTICLES WERE RATED AS CONCOMITANT DEVICES. NO INVESTIGATION TOOK PLACE. 1X 04.016.035S / 5942694 MULTILOC SHORT NAIL; 1X 04.005.442S / L395348 (LOCKING SCREW STARDRIVE® Ø 4.0MM, L 52MM); 1X UNK DISTAL SCREW; 1X 03.019.020 / 9853802 (SCREWDRIVER SCRDRIVER T25); 1X SCRDRIVER T25 W/COUPL F, 03.019.019/ LOT UNKNOWN; 1X 03.010.063 / L021144PROTECTION SLEEVE 12.0/8.0, L 188MM; 1X TROCAR Ø3.2 F, 03.010.064/ 8892097; 1X TROCAR Ø3.2 F, 03.010.064/ 8892097; 1X 03.010.060 / 9899543 DRILL BIT Ø3.2 CALIBR L340 3FLUTE; 1X 03.010.060 /9899543 DRILL BIT Ø3.2 CALIBR L340 3FLUTE; 1X DRILLSL 8/3.2 F, 03.010.064 / 9320770; 1X DRILLSL 8/3.2 F, 03.010.064 / 9320770; CONCLUSION: WE HAVEN'T RECEIVED ANY FURTHER INFORMATION BACK FROM AFFILIATES/USER/HOSPITAL. SALES AND COMPLAINT ANALYSIS FOR INTERACTION ISSUE BETWEEN NAIL AND LOCKING SCREWS GOT PERFORMED BY SUSTAINING ENGINEERING TEAM. THE APPLICABLE DCRM DOES ADEQUATELY ADDRESS THE INTERACTION ISSUE BETWEEN MULTILOC NAIL AND LOCKING SCREWS. BASED ON THE AVAILABLE INFORMATION, NO FURTHER EVALUATION CAN BE CONDUCTED AND THE PRODUCT IS SAFE AND EFFICIENT. BASED ON THE VISUAL EXAMINATION, DHR-REVIEW AND DCRM-REVIEW WE COULD NOT CONFIRM THE COMPLAINED ISSUE. COMPLAINT UNCONFIRMED. NEITHER ANY MANUFACTURING RELATED FAULT COULD BE FOUND. WE DO STRONG RECOMMEND FOLLOWING THE SURGICAL TECHNIQUE. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED SURGICAL TOOL KIT WAS USED IN SURGERY FOR THE HUMERAL SURGICAL NECK FRACTURE ON (B)(6) 2017. THE MULTILOC SHORT NAIL WAS USED FOR THE PROCEDURE. THE NAIL INSERTION AND PROXIMAL SCREW INSERTION WERE DONE WITHOUT ANY PROBLEM. WHEN THE SURGEON WAS INSERTING THE FIRST DISTAL SCREW AFTER DRILLING, THE SCREW IN QUESTION DID NOT MOVE FORWARD FROM THE MIDDLE. THE SECOND SCREW WAS INSERTED INTO ANOTHER HOLE WITHOUT ANY PROBLEM. ALTHOUGH THE SURGEON TRIED TO INSERT THE FIRST SCREW SEVERAL TIMES AFTER RE-DRILLING, THE SCREW COULD NOT BE INSERTED INTO THE HOLE. THE SCREW HAD BEEN DISENGAGED ANTERIORLY TO THE NAIL. THE SURGERY WAS COMPLETED WITH ONLY ONE DISTAL SCREW (THE SECOND SCREW) INSERTED. A DRY-RUN OF INSERTION WAS PERFORMED BEFORE THE SURGERY, NO PROBLEM WAS IDENTIFIED. THE SURGERY WAS EXTENDED FOR THIRTY (30) MINUTES. NO PATIENT HARM WAS REPORTED, PATIENT OUTCOME IS OKAY. CONCOMITANT DEVICES: LOCKING SCREW (PART 04.016.035S, LOT 5942694, QUANTITY 1); DISTAL SCREW (PART/LOT UNKNOWN, QUANTITY 1); SCREWDRIVER (PART 03.019.020, LOT 9853802, QUANTITY 1); PROTECTION SLEEVE (PART 03.010.063, LOT L021144, QUANTITY 1); TROCAR (PART 03.010.069, LOT UNKNOWN, QUANTITY 2); DRILL BIT (PART 03.010.060, LOT 9899543, QUANTITY 2); DRILL SLEEVE (PART 03.010.064, LOT 9320770, QUANTITY 2). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE: 24 AUG 2017. CONCOMITANT DEVICES: 1X 04.016.035S / 5942694 (LOCKING SCREW STARDRIVE® Ø 4.0MM, L 52MM), 1X UNK DISTAL SCREW, 1X 03.019.020 / 9853802 (SCREWDRIVER SCRDRIVER T25), 1X SCRDRIVER T25 W/COUPL F, 03.019.019/ LOT UNKNOWN, 1X PROTECT SLEEVE 12/8, PART/ LOT UNKNOWN, 1X TROCAR Ø3.2 F, 03.010.064/ LOT UNKNOWN, 1X TROCAR Ø3.2 F, 03.010.064/ LOT UNKNOWN, 1X DRILL BIT Ø3.2 CALIBR L340 3FLUTE, PART / LOT UNKNOWN, 1X DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/03.0, PART/ LOT UNKNOWN, 1X DRILLSL 8/3.2 F, 03.010.063/ LOT UNKNOWN, 1X DRILLSL 8/3.2 F, 03.010.063/ LOT UNKNOWN.

    Description of Event or Problem · 1

    CONCOMITANT DEVICES REPORTED: 8MM MULTILOC PROXIMAL HUMERAL. NAIL/LEFT/CANNULATED/160MM (04.016.035S, LOT 5942694, QUANTITY 1), 4.0MM LOCKING SCREW WITH T25 STARDRIVER FOR IM NAILS (04.005.442S, LOT L395348, QUANTITY 1), DISTAL SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), STARDRIVE SCREWDRIVER (03.019.020, LOT 9853802, QUANTITY 1), CENTERING SLEEVE FOR 3.5MM LOCKING SCREW (03.019.019, LOT NUMBER UNKNOWN, QUANTITY 1), 12.0MM/8.0MM PROTECTION SLEEVE (03.010.063, LOT L021144, QUANTITY 1), 8.0MM/3.2MM DRILL SLEEVE (03.010.064, LOT 8892097, QUANTITY 2), 8.0MM/3.2MM DRILL SLEEVE (03.010.064, LOT 9320770, QUANTITY 2),3.2MM THREE FLUTED DRILL BIT (03.010.060, LOT 9899543, QUANTITY 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601001 AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES HAGENDORF L041783 07611819425583

    Patients

    Seq Age Sex Outcome Treatment
    1