BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: ASLS

    MDR report key: 20799031 · Received November 27, 2024

    Report

    Report Number
    8030965-2024-14460
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    March 1, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: 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 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: IDELER N, BRAUNS J, VANDESANDE W. SUPRAPATELLAR TIBIAL NAILING: INTRAOPERATIVE ARTHROSCOPIC EVALUATION AND RESULTS AT A MINIMUM OF 12 MONTHS FOLLOW-UP. ACTA ORTHOP BELG. 2024 MAR;90(1):90-95. DOI: 10.52628/90.1.12063. PMID: 38669656. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY IS TO ASSESS PERI-SERTION OF AN INTRAMEDULLARY NAIL (IMN) AND TO ASSESS 1-YEAR CLINICAL AND RADIOLOGICAL RESULTS OF THE TREATMENT OF TIBIAL FRACTURES AFTER INTRAMEDULLARY NAILING USING THE SUPRAPATELLAR (SP) APPROACH. THIS IS A SINGLE SURGEON, RETROSPECTIVE, CONSECUTIVE, OBSERVATIONAL STUDY. PATIENTS WITH A TIBIAL FRACTURE UNDERWENT INTRAMEDULLARY TIBIAL NAILING FROM FEBRUARY 2015 TO MARCH 2019. 36 PATIENTS WERE INCLUDED IN THIS STUDY, WITH A MINIMAL FOLLOW-UP OF 12 MONTHS. THE SYNTHES EXPERT TIBIAL NAIL IS INSERTED UNDER AP AND LATERAL FLUOROSCOPIC VISUALIZATION UNTIL THE DESIRED DEPTH IS REQUIRED. AFTER OPTIMAL POSITION OF THE NAIL AND REDUCTION OF THE FRACTURE, DISTAL ANGULAR STABLE LOCKING SYSTEM (ASLS) SCREWS ARE INSERTED. DISTAL ASLS SCREWS WERE USED IN ALL PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ANGULAR STABLE LOCKING SYSTEM (ASLS) SCREWS, DEPUY SYNTHES AND SYNTHES EXPERT TIBIAL NAIL ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: EXPERT TIBIAL NAIL (QTY (B)(4) -1 PATIENT HAD A POSTOPERATIVE WOUND INFECTION AFTER A GUSTILO-ANDERSON TYPE 1A OPEN FRACTURE, FOR WHICH IRRIGATION OF THE WOUND AND ANTIBIOTIC THERAPY WAS NEEDED 1 WEEK AFTER SURGERY. -1 PATIENT DEVELOPED PSORIASIS AROUND THE SCAR. NO INTERVENTION NOTED. -2 PATIENTS DEVELOPED COMPLEX REGIONAL PAIN SYNDROME (CRPS), WHICH RESOLVED AFTER TREATMENT WITH SUBCUTANEOUS INJECTIONS OF CALCITONIN. -3 PATIENTS DEVELOPED A DELAYED UNION OF THE FRACTURE. DYNAMIZATION OF THE NAIL WAS REQUIRED IN 2 PATIENTS DUE TO A DELAYED UNION, IN WHICH THE PROXIMAL SCREWS OF THE NAIL WERE REMOVED. 1 PATIENT WAS TREATED NONOPERATIVELY AND HEALED AFTER 12 MONTHS POSTOPERATIVELY. -3 PATIENTS HAD LOW-GRADE INFECTION. 1 PATIENT REQUIRED REMOVAL OF THE NAIL AND PROXIMAL SCREW. THE PATIENT REPORTED SIGNIFICANTLY LESS PAIN AND COULD WEIGHT BEAR BETTER AFTER REMOVAL OF THE NAIL. THEREFORE, FURTHER CONSERVATIVE THERAPY WAS PURSUED AND RADIOLOGICAL FOLLOW-UP SHOWED A PSEUDARTHROSIS AT 26 MONTHS FOLLOW-UP. ANOTHER PATIENT REQUIRED AN IMN WITH A WIDER DIAMETER (+ 2 MM) WAS PLACED AFTER INTRAMEDULLARY REAMING, COMBINED WITH AN IPSILATERAL NON-VASCULARIZED FIBULA BONE GRAFT AFTER RULING OUT AN INFECTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: NAIL PROXIMAL LOCKING (QTY (B)(4). -3 PATIENTS REQUIRED SCREW REMOVAL DUE TO IRRITATION OR LOW-GRADE INFECTION AROUND THE SCREW ENTRY POINTS. 1 PATIENT REPORTED SIGNIFICANTLY LESS PAIN AND COULD WEIGHT BEAR BETTER AFTER REMOVAL OF THE NAIL. THEREFORE, FURTHER CONSERVATIVE THERAPY WAS PURSUED AND RADIOLOGICAL FOLLOW-UP SHOWED A PSEUDARTHROSIS AT 26 MONTHS FOLLOW-UP. ANOTHER PATIENT REQUIRED AN IMN WITH A WIDER DIAMETER (+ 2 MM) WAS PLACED AFTER INTRAMEDULLARY REAMING, COMBINED WITH AN IPSILATERAL NON-VASCULARIZED FIBULA BONE GRAFT AFTER RULING OUT AN INFECTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: ASLS (QTY (B)(4). -1 PATIENT HAD A POSTOPERATIVE WOUND INFECTION AFTER A GUSTILO-ANDERSON TYPE 1A OPEN FRACTURE, FOR WHICH IRRIGATION OF THE WOUND AND ANTIBIOTIC THERAPY WAS NEEDED 1 WEEK AFTER SURGERY. -1 PATIENT DEVELOPED PSORIASIS AROUND THE SCAR. NO INTERVENTION NOTED. -2 PATIENTS DEVELOPED COMPLEX REGIONAL PAIN SYNDROME (CRPS), WHICH RESOLVED AFTER TREATMENT WITH SUBCUTANEOUS INJECTIONS OF CALCITONIN. -3 PATIENTS DEVELOPED A DELAYED UNION OF THE FRACTURE. DYNAMIZATION OF THE NAIL WAS REQUIRED IN 2 PATIENTS DUE TO A DELAYED UNION, IN WHICH THE PROXIMAL SCREWS OF THE NAIL WERE REMOVED. -3 PATIENTS REQUIRED SCREW REMOVAL DUE TO IRRITATION OR LOW-GRADE INFECTION AROUND THE SCREW ENTRY POINTS. 1 PATIENT REPORTED SIGNIFICANTLY LESS PAIN AND COULD WEIGHT BEAR BETTER AFTER REMOVAL OF THE NAIL. THEREFORE, FURTHER CONSERVATIVE THERAPY WAS PURSUED AND RADIOLOGICAL FOLLOW-UP SHOWED A PSEUDARTHROSIS AT 26 MONTHS FOLLOW-UP. ANOTHER PATIENT REQUIRED AN IMN WITH A WIDER DIAMETER (+ 2 MM) WAS PLACED AFTER INTRAMEDULLARY REAMING, COMBINED WITH AN IPSILATERAL NON-VASCULARIZED FIBULA BONE GRAFT AFTER RULING OUT AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850758 UNK - SCREWS: ASLS SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention