BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARUS® 3 PROXIMAL LOCKING NAIL 150MM L

    MDR report key: 21104546 · Received January 8, 2025

    Report

    Report Number
    3025141-2025-00009
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 6, 2024
    Report Date
    January 20, 2025
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS CURRENTLY PENDING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REPORTED POLARUS® 3 PROXIMAL LOCKING NAIL 150MM L WAS RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE POLARUS® 3 PROXIMAL LOCKING NAIL 150MM L (PART NUMBER 4001-1015L-S, BATCH NUMBER 589991) WAS EXAMINED VISUALLY UNDER MAGNIFICATION. THE IMPLANT WAS PROVIDED IN TWO PIECES: THE MAIN NAIL PORTION, AND THE SEPARATED PEEK SLEEVE. THE DESCRIPTION OF EVENT AND PROCEDURE COMPLETION STATED: "WHEN THE SURGEON TRIED TO GET THE NAIL OUT USING K-WIRE, THE INTERNAL PEEK SLEEVE REMOVED FROM THE NAIL." THE FIELD CONTACTS SPECIFICALLY STATED, "WHEN THE SURGEON TRIED TO GET THE NAIL OUT USING K-WIRE," WHICH INDICATED THE IN-FIELD USER MAY HAVE DIRECTLY OR INDIRECTLY ATTEMPTED TO USE A K-WIRE AS AN INSTRUMENT ASSISTING THE REMOVAL PROCESS. PER THE POLARUS 3 SOLUTION SURGICAL TECHNIQUE (SHD10-06-J) ON PDF PAGE 30 / IN-DOCUMENT PAGE 28, STEP 12 PROVIDES THE PROPER GUIDANCE ON IMPLANT REMOVAL. STEP 12 DIRECTLY NOTES SEVERAL DEVICES INTENDED FOR USE IN AIDING THE NAIL REMOVAL PROCESS (E.G. 80-1618, 80-1635, 80-1546, AND 80-1538); STEP 12 OF THE SURGICAL TECHNIQUE MAKES NO NOTE WHATSOEVER SUPPORTING THE USAGE OF A K-WIRE TO REMOVE THE NAIL. ACCOMPANYING FIGURES 25 AND 26 USED ALONGSIDE STEP 12 ALSO DO NOT VISUALLY DEPICT A K-WIRE. AS SUCH, PER THE COMMENTARY FROM THE FIELD, THE PROVIDED STATEMENT REGARDING THE IN-FIELD REMOVAL PROCEDURE APPEARS TO SUGGEST THE USER'S REMOVAL PROCEDURE MISALIGNED WITH THE SYSTEM SURGICAL TECHNIQUE AS IT SUGGESTS A K-WIRE MAY HAVE BEEN INTENTIONALLY USED IN SOME MANNER TO ASSIST WITH REMOVING THE NAIL. IT IS POSSIBLE THAT THE USER'S POTENTIAL NONALIGNMENT WITH THE SURGICAL TECHNIQUE CONTRIBUTED TO ISSUES EXPERIENCED DURING THE REMOVAL PROCESS (THE PEEK SLEEVE DISLODGING FROM THE INTERNALLY THREADED END OF THE NAIL). THE NAIL SUBCOMPONENT EXHIBITED DAMAGE/WEAR NEAR THE INTERNALLY THREADED END OF THE DEVICE. THIS DAMAGE WAS PRESENT ON INTERNAL AND EXTERNAL FEATURES. THIS DAMAGE WAS PREVALENT AROUND THE REARMOST HOLE, EXTERNAL SURFACES ADJACENT TO SAID HOLE, THE REARMOST HOLE CLUSTER, THE RECTANGULAR NOTCH IN THE DEVICE, THE REAR EDGE OF THE IMPLANT, AND INTERNAL THREADING. THIS DAMAGE/WEAR TOOK THE FORM OF SCRATCHES, INDENTATIONS/NICKS, SURFACE FINISH WEAR EXPOSING BARE METAL, BROWN CORROSION/DISCOLORATION, AND SIMILAR PHENOMENA. INTERNAL THREADING WAS HEAVILY WORN AT PEAKS/CRESTS ALONG SEVERAL TURNS OF THREAD. THE DESCRIPTION OF EVENT AND PROCEDURE COMPLETION STATED: "WHEN INSERTING POLARUS® 3 PROXIMAL LOCKING NAIL 150MM L (PART NUMBER 4001-1015L-S, BATCH NUMBER 589991), THE PATIENT'S MEDULLARY CAVITY WAS TOO NARROW, AND THE NAIL WAS DIFFICULT TO INSERT. THE SURGEON MANAGED TO INSERT THE NAIL WHILE TWISTING, THE NAIL DETACHED FROM POLARUS® 3 NAIL TARGETING LOCKING BOLT (PART NUMBER 80-1625)." GIVEN THE FORM OF THE NAIL IS NOT IMPLICATED PER DIMENSIONAL CHECKS PERFORMED, IT IS POSSIBLE THE OBSERVED INSERTION DIFFICULTY RELATES TO SOME ASPECT OF THE NARROWER IM CANAL / MEDULLARY CAVITY AND/OR THE USER'S TECHNIQUE DURING INSERTION. CONTRIBUTING FACTORS INVOLVING THE AS-PREPARED CANAL COULD RELATE TO SEVERAL POTENTIAL TOPICS INCLUDING PATIENT-SPECIFIC ANATOMY, THE EXACT CANAL PREPARATION TECHNIQUE EMPLOYED BY THE IN-FIELD USER, AND/OR THE CONDITION OF THE INSTRUMENTS USED IN PREPARATION OF THE CANAL. THIS CANNOT BE CONFIRMED, AS THE FIELD CONTACT HAS NOT PROVIDED FURTHER DETAILS ON THE USER'S CANAL PREPARATION METHODOLOGY AND THE FIELD CONTACT HAS FAILED TO RETURN ALL PARTS RELEVANT TO THE INCIDENT (READ: THE FIELD CONTACT FAILED TO RETURN ALL RELEVANT INSTRUMENTATION USED IN THE CANAL PREPARATION PROCESS AND THE NAIL INSERTION PROCESS, MEANING THAT SAID INSTRUMENTATION CANNOT BE EVALUATED TO DETERMINE IF ANY INSTRUMENT-SIDE ISSUES COULD POSSIBLY HAVE CONTRIBUTED TO THE ALLEGED IN-FIELD EVENT). HOWEVER, BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED. CORRECTED DATA: TYPE OF INVESTIGATION CODE (ANNEX B): UPDATED 3331 AND 10 INVESTIGATION FINDINGS CODE (ANNEX C): UPDATED TO 3243 AND 4248. INVESTIGATION CONCLUSIONS CODE (ANNEX D): UPDATED TO 4315.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING SURGERY THAT WHEN THE SURGEON ATTEMPTED TO INSERT THE POLARUS® 3 PROXIMAL LOCKING NAIL 150MM L THE PATIENT'S MEDULLARY CAVITY WAS TOO NARROW MAKING IT DIFFICULT TO INSERT. THE SURGEON MANAGED TO INSERT THE NAIL, BUT WHILE TWISTING, THE NAIL DETACHED FROM POLARUS® 3 NAIL TARGETING LOCKING BOLT. THE SURGEON TRIED TO GET THE NAIL OUT USING A K-WIRE, THE INTERNAL PEEK SLEEVE ALSO REMOVED FROM THE NAIL. THE SURGERY WAS COMPLETED WITH A POLARUS® 3 LOCKING NAIL 200MM AFTER A 2-HOUR DELAY. NO OTHER PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348458 POLARUS® 3 PROXIMAL LOCKING NAIL 150MM L ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 4001-1015L-S 589991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown