BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - ELASTIC NAILS: TITANIUM

    MDR report key: 11770531 · Received May 4, 2021

    Report

    Report Number
    8030965-2021-03538
    Event Type
    Injury
    Date Received
    May 4, 2021
    Report Date
    April 8, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNK - ELASTIC NAILS: TITANIUM/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL: REISSNER L ET AL. (2010), TREATMENT OF CLAVICULAR MIDSHAFT FRACTURES WITH TEN AND ENDCAP ¿ REDUCED COMPLICATIONS BY CAREFUL OPERATIVE TECHNIQUE AND LIMITED RANGE OF MOTION, SPORTORTHOTRAUMA, VOLUME 26, PAGE 247-253, (SWITZERLAND). THE PRESENT STUDY EXAMINED BY WHAT FURTHER MEASURES THE COMPLICATION RATE CAN BE LOWERED FURTHER TO AN ACCEPTABLE LEVEL. FROM APRIL 2004 TO DECEMBER 2009, 63 PATIENTS (51 MEN, 12 WOMEN) WITH A CLAVICULAR MIDSHAFT FRACTURE UNDERWENT INTRAMEDULLARY FIXATION WITH TITANIUM ELASTIC NAIL (TEN) USING AN UNKNOWN SYNTHES TITANIUM ELASTIC NAIL. THE MEAN AGE WAS 32 (RANGE 16-74) YEARS. THE PATIENTS WERE DIVIDED INTO 3 GROUPS. IN GROUP A (19 PATIENTS) FROM APRIL 2004 TO AUGUST 2005 THE PATIENTS WERE TREATED USING TEN WITHOUT ENDCAP. DUE TO FREQUENT MEDIAL PERFORATION OF THE TEN AND PAIN AT THE INSERTION SITE, THE OPERATING METHOD WAS CHANGED. IN GROUP B (15 PATIENTS), FROM MARCH 2006 TO MARCH 2007 THE PATIENTS WERE TREATED USING TEN WITH ENDCAP, TEN WAS INSERTED WITH A DRILL WITH AN OSCILLATING FUNCTION. GROUP A AND B WERE ALLOWED TO MOVE THE ARM POSTOPERATIVELY FREELY AND A RETURN TO THE SPORT WAS ALLOWED AS SOON AS POSSIBLE. AFTER OCCURRENCE OF MANY COMPLICATIONS, THE TREATMENT WAS ADJUSTED IN GROUP C (29 PATIENTS) FROM DECEMBER 2007 TO DECEMBER 2009. THE PATIENTS WERE TREATED WITH A TEN WITH ENDCAP WHERE THE TEN WAS INSERTED USING T-HANDLE. THE ABDUCTION AND FLEXION WERE RESTRICTED FOR 6 WEEKS ON 908 AND A SPORT LEAVE FOR 6 WEEKS WAS PRESCRIBED. CLINICAL AND RADIOLOGICAL CONTROLS WERE CARRIED OUT SIX AND 12 WEEKS POSTOPERATIVELY. A MATERIAL REMOVAL TOOK PLACE AFTER SECURE RADIOLOGICAL CONSOLIDATION 4 TO 6 MONTHS POSTOPERATIVELY. COMPLICATIONS WERE REPORTED: GROUP A (WITHOUT ENDCAP): 7 PATIENTS HAD MEDIAL PERFORATION. 3 PATIENTS HAD LATERAL PERFORATION. 4 PATIENTS HAD SEVERE MEDIAL PAIN. UNKNOWN PATIENTS HAD PAIN AT THE INSERTION SITE. GROUP B (WITH ENDCAP): 3 PATIENTS HAD REOPERATION AND TREATMENT OF THE FRACTURE WITH A PLATE FIXATION WERE REQUIRED. 4 PATIENTS HAD PERFORATION OF THE NAIL IN THE REGION OF THE LATERAL END OF THE CLAVICLE. 1 PATIENT HAD FRACTURE OF THE NAIL. 1 PATIENT HAD DISLOCATIONS OF THE NAIL. 4 PATIENTS HAD EITHER MEDIAL OR LATERAL PAIN. GROUP C (WITH ENDCAP): 1 PATIENT HAD LATERAL CORTEX PERFORATION LEADING TO PREMATURE METAL REMOVAL AFTER 2 MONTHS. 1 PATIENT HAD POSTOPERATIVE THROMBOSIS OF THE SUBCLAVIAN VEIN, WHICH REQUIRED 3-MONTH ANTICOAGULATION. 1 PATIENT HAD A NON-UNION AT 13 MONTHS AND WAS SWITCHED TO PLATE. THIS REPORT IS FOR THE UNKNOWN SYNTHES TITANIUM ELASTIC NAILS AND UNKNOWN SYNTHES TITANIUM ELASTIC NAIL ENDCAPS. THIS REPORT IS FOR (1) UNK - ELASTIC NAILS: TITANIUM. THIS REPORT IS 3 OF 4 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666636 UNK - ELASTIC NAILS: TITANIUM NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention