BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO-PRO LOCK SCRW,SS 2.7X 14MM

    MDR report key: 22782703 · Received August 12, 2025

    Report

    Report Number
    1220246-2025-03432
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 18, 2025
    Report Date
    November 3, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047051
    PMA / PMN Number
    K143614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-8827L-14 BATCH UNK WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED DAMAGE TO BOTH THE HEAD HEXALOBE AND THE BODY THREADS. THE THREADS AT THE HEAD APPEARED STRIPPED. THE OBSERVED DAMAGE IS CONSISTENT WITH MECHANICAL STRESS, LIKELY INCURRED DURING USE OR HANDLING. FURTHER EVALUATION UNDER MAGNIFICATION AND MICRO-VU MEASUREMENT IDENTIFIED A POSSIBLE MANUFACTURING DEFECT¿SOME THREADS ON THE HEAD WERE NOT FULLY FORMED. THE DEVICE WAS EVALUATED ACCORDING TO THE DRAWING SPECIFICATION. C1330 AT REVISION 11, COMPONENT C1330-03 AT REVISION 9. OVERALL LENGTH: 0.551 ± 0.012 INCHES. RESULTS: 0.541 INCHES . HEAD MAJOR THREAD DIAMETER: 0.161 + 0.001/-0.000. INCHES, RESULTS: 0.157 INCHES HEAD MINOR THREAD DIAMETER: 0.139 + 0.001/-0.000. INCHES, RESULTS: 0.141 INCHES THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A MANUFACTURING ISSUE. HOWEVER, SINCE THE BATCH NUMBER IS UNKNOWN, NO FURTHER ACTION CAN BE TAKEN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-8827L-14 BATCH UNK WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED DAMAGE TO BOTH THE HEAD HEXALOBE AND THE BODY THREADS. THE THREADS AT THE HEAD APPEARED STRIPPED. THE OBSERVED DAMAGE IS CONSISTENT WITH MECHANICAL STRESS, LIKELY INCURRED DURING USE OR HANDLING. A FUNCTIONAL TEST WAS PERFORMED USING A WELL-KNOWN GOOD PLATE (AR-2656DL), AND IT WAS OBSERVED THAT THE SCREW SITS IN THE PLATE'S HOLE. HOWEVER, WHEN THE SCREW IS MOVED USING THE THREADED PORTION OF THE BODY, IT DISENGAGES EASILY, WHICH COULD POTENTIALLY AFFECT PROPER PLATE PLACEMENT. FURTHER EVALUATION UNDER MAGNIFICATION AND MICRO-VU MEASUREMENT IDENTIFIED A POSSIBLE MANUFACTURING DEFECT¿SOME THREADS ON THE HEAD WERE NOT FULLY FORMED. THE DEVICE WAS EVALUATED ACCORDING TO THE DRAWING SPECIFICATION. C1330 AT REVISION 11, COMPONENT C1330-03 AT REVISION 9. OVERALL LENGTH: 0.551 ± 0.012 INCHES. RESULTS: 0.541 INCHES. HEAD MAJOR THREAD DIAMETER: 0.161 + 0.001/-0.000. INCHES, RESULTS: 0.157 INCHES. HEAD MINOR THREAD DIAMETER: 0.139 + 0.001/-0.000. INCHES, RESULTS: 0.141 INCHES. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A MANUFACTURING ISSUE, AS THE HEAD THREADS APPEAR TO BE MISSING OR NOT PROPERLY FORMED. HOWEVER, SINCE THE BATCH NUMBER IS MISSING, FURTHER INVESTIGATION CANNOT BE COMPLETED. WITHOUT THIS INFORMATION, NO FURTHER ACTION CAN BE TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE CLAVICLE FRACTURE PLATING SURGERY THAT THE SCREW STRIPPED WHEN FIXING IT IN THE PLATE AND THE UPPER THREAD OF THE SCREW DID NOT ENGAGE THE PLATE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339814 LO-PRO LOCK SCRW,SS 2.7X 14MM BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO LOCK SCRW,SS 2.7X 14MM UNK 00888867047051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown