BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECSCR F/CFN/AFN F/SYNREAM

    MDR report key: 4378023 · Received January 2, 2015

    Report

    Report Number
    2520274-2015-10015
    Event Type
    Injury
    Date Received
    January 2, 2015
    Date of Event
    December 3, 2014
    Report Date
    December 3, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. YEAR OF BIRTH (B)(6), MONTH/DATE UNKNOWN. INSTRUMENT, NOT IMPLANTED OR EXPLANTED. UNKNOWN CONNECTING SCREW, PART AND LOT ARE UNKNOWN. THE PART WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS THE PART WAS NOT RECEIVED. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: ARTICLES 357.521 (INSERTION HANDLE), 477.170 (NAIL-IMPLANT) AND 398.335 (CONNECTING SCREW) WERE RECEIVED JAMMED TOGETHER. THESE ARE ALL PART OF THE UFN SET. IN AN EFFORT TO DISASSEMBLE THE PARTS HEX SCREW DRIVER (357.515) FROM AN INTERNAL DEMO SET WAS USED. THE CONNECTING SCREW COULD NOT BE LOOSENED USING THE INSTRUMENTATION IN THE SET. AN 8MM ALLEN WRENCH WITH A COMBINATION WRENCH WAS USED TO LOOSEN THE CONSTRUCT. THE CONNECTING SCREW WAS JAMMED INTO THE NAIL IMPLANT. IN THE PROCESS OF ATTEMPTING TO LOOSEN THE CONNECTING SCREW, THE NAIL IMPLANT ROTATED WITH THE SCREW BREAKING THE TABS ON THE INSERTION HANDLE. THIS IS EVIDENCE THAT THE ISSUE LIES AT THE NAIL CONNECTING SCREW INTERFACE AND NOT AT THE NAIL, INSERTION HANDLE INTERFACE AS THE REPORTED COMPLAINT SUGGESTS. LIKELY IS THAT THE CONNECTING SCREW WAS JAMMED AT DAMAGED IMPLANT THREAD. THE NAIL IMPLANT SHOWS EVIDENCE OF DAMAGE AT THE NAIL THREADS AND THE TOP SURFACE OF THE NAIL SHOWS UNEVEN WEAR. DUE TO THE CIRCUMSTANCES AROUND THIS INCIDENT THE CAUSE OF THE THREAD DAMAGE AND UNEVEN WEAR AT THE TOP SURFACE CANNOT BE CONCLUDED. THIS MAY HAVE HAPPENED DURING IMPLANTATION, END CAP INSERTION OR REMOVAL (IF THERE WAS ONE), OR NAIL REMOVAL. THE CONNECTING SCREW SHOWS VISIBLE SIGNS OF MULTIPLE USES BUT NO VISIBLE DAMAGE. FURTHER THE NAIL IMPLANT WAS IMPLANTED FOR A NUMBER OF YEARS BEFORE THIS REPORTED INCIDENT. AT SOME POINT THE NAIL WAS DEFORMED, BECAUSE THE RETURNED IMPLANT WAS VISIBLY BENT. BASED ON THE EVIDENCE AND COMPLAINT DESCRIPTION NO CONCLUSIONS CAN BE MADE IF THIS DEFORMATION HAPPENED IN THE INITIAL IMPLANTATION, DURING THE OSTEOTOMY REPORTED IN THE COMPLAINT DURING WHICH THE IMPLANT WAS TWISTED, OR DURING NAIL EXTRACTION. THIS DEFORMATION WAS LIKELY WHAT PREVENTED THE LOCKING OF THE NAIL. IMPLANTS ARE ONLY INTENDED TO BE USED ONCE AND ARE NOT DESIGNED TO BE REPOSITIONED AND RELOCKED IN A SECOND PROCEDURE. IN CONCLUSION, BASED ON THE CIRCUMSTANCES IN THE COMPLAINT DESCRIPTION AND THERE IS NO CONCLUSIVE EVIDENCE THAT THE JAMMING OF THE INSERTION HANDLE, CONNECTING SCREW, AND IMPLANT CONSTRUCT LIES IN A MANUFACTURING OR DESIGN FLAW. LIKEWISE NO CONCLUSIONS CAN BE MADE AS TO WHY THE IMPLANT COULD NOT BE LOCKED DURING PROCEDURE BASED ON THE EVIDENCE AT HAND. 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 IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT 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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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, A (B)(6) YEARS OLD (B)(6), AIMING ARM DOES NOT FIT ON THE NAIL, NAIL TWISTS. THIS OCCURRED DURING SURGERY AND CAUSED A 60 MINUTE DELAY. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT IS OKAY, NO PROBLEM. OLD NAIL HAS BEEN REPLACED BY A NEW ONE, SAME DIAMETER, SAME LENGTH. SURGEON HAS DONE AN OSTEOTOMY OF THE FEMUR, THEN HE TRIED TO TURN THE NAIL TOGETHER WITH THE AIMING ARM, AFTER THAT HE DID NOT FOUND THE HOLES IN THE NAIL ANYMORE FOR LOCKING. FURTHER CLARIFICATION REGARDING THE REPORT EVENT AS FOLLOWS: PATIENT SUFFERED FROM A NEW, MINOR FEMUR FRACTURE (NO CLINICAL DETAILS AVAILABLE). SURGEON PERFORMED A CORRECTION OSTEOTOMY ON THE LEVEL OF THE FIRST THIRD OF THE PROXIMAL FEMUR. AFTER THE SUCCESSFUL OSTEOTOMY THE SURGEON WANTED TO TURN THE NAIL WITH THE AIMING ARM, SUBSEQUENTLY THE NAIL TWISTED AND IT WAS NOT POSSIBLE TO LOCK THE NAIL APPROPRIATELY. THE NAIL NEEDED TO BE REPLACED BY A NEW ONE (SAME DIAMETER, SAME LENGTH). THIS REPORT IS FOR AN UNKNOWN TRAUMA DEVICE. THIS IS 3 OF 3 REPORTS FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350 CONNECSCR F/CFN/AFN F/SYNREAM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES BETTLACH 2024751N1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention