BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE 120MM

    MDR report key: 4436822 · Received January 21, 2015

    Report

    Report Number
    3003875359-2015-10053
    Event Type
    Malfunction
    Date Received
    January 21, 2015
    Report Date
    January 6, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    GAD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (BLADE 120MM, PART NUMBER 03.816.120, LOT NUMBER 8173644). AS PREVIOUSLY REPORTED, A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THERE WERE NO COMPLAINT-RELATED NON-CONFORMANCES GENERATED DURING PRODUCTION OF THE SUBJECT DEVICE LOT. THERE WAS NO ISSUES DURING THE MANUFACTURE OF THE SUBJECT DEVICE THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION OF ¿THE PROXIMAL END OF BLADE HAS SNAPPED OFF.¿ THE REPORTED ISSUE HAS BEEN INVESTIGATED WITH THE DEVICE COUNTERPARTS, PART NUMBER 03.816.011 (BLADE REMOVAL INSTRUMENT), PART NUMBER 03.816.011 (BLADE REMOVER SLEEVE) AND PART NUMBER 03.816.004 (THIRD BLADE HOLDER). FIRST THE BLADE WAS ATTACHED ON THE THIRD BLADE HOLDER. THEN THE BLADE WAS DETACHED AND UNLOCKED WITH THE BLADE REMOVAL INSTRUMENT WITHOUT ANY PROBLEMS. NO MALFUNCTION WAS DETECTED. ONE END OF THE BLADE IS SEVERELY DAMAGED. THIS TYPE OF DAMAGE TO THE BLADE INDICATES A MISHANDLING. 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

    THE DATE OF RETURN TO THE MANUFACTURER HAS BEEN FURTHER CLARIFIED AND CONFIRMED TO HAVE OCCURRED ON FEB 25, 2015. DEVICE 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

    MANUFACTURING INVESTIGATION: THE REPORTED ISSUE HAS BEEN INVESTIGATED WITH THE COUNTERPARTS, PART 03.816.011 (BLADE REMOVAL INSTRUMENT), PART 03.816.011 (BLADE REMOVER SLEEVE), AND PART 03.816.004 (THIRD BLADE HOLDER). FIRST, THE BLADE GETS ATTACHED ONTO THE THIRD BLADE HOLDER. THEN, THE BLADE HAS BEEN DETACHED AND UNLOCKED WITH THE BLADE REMOVAL INSTRUMENT WITHOUT ANY PROBLEMS. NO MALFUNCTION HAS BEEN DETECTED. ONE END OF THE BLADE IS STRONGLY DAMAGED. THE DAMAGE TO THE BLADE INDICATES A MISHANDLING. THE COMPLAINT CONDITION IS CONFIRMED, BUT NOT MANUFACTURING RELATED. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED; THEREFORE, REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. PRODUCT INVESTIGATION: THE INDIVIDUAL PIECE WAS RECEIVED IN A NON-STERILE STATE. A FRAGMENT OF THE PART WAS MISSING AND NOT RETURNED. PRODUCT WAS BROKEN AT THE INTERFACE BETWEEN THE BLADE AND THE BLADE REMOVAL TOOL (03.816.011). BREAKAGE DUE TO MISHANDLING IN COMBINATION WITH 03.816.011 AND 03.816.016 HAS BEEN DETERMINED. DEVICE 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

    THIS 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

    IT WAS REPORTED THAT ON (B)(6) 2015 WHILE THE SALES CONSULTANT WAS CONDUCTING AN IN-SERVICE WITH THE SURGEON AND TECHNICIAN ON THE INSIGHT RETRACTOR, SHE OBSERVED THE FLANGE ON THE END OF THE INSTRUMENT WAS BENT (IT WAS RECEIVED BENT). IT WAS STATED THAT THE DISTAL END OF THE INSTRUMENT BENDS PRIOR TO REMOVING THE BLADES. BECAUSE IT BENDS, ADDITIONAL FORCE IS REQUIRED TO ATTEMPT REMOVAL OF THE BLADES. FOR ANOTHER PART, IT WAS REPORTED THAT THE DISTAL END OF THE ADDITIONAL BLADE IS JAMMED AND WILL NOT RETRACT. FOR ANOTHER PART, IT WAS REPORTED THAT THE PROXIMAL END OF THE BLADE (WHERE THE BLADE REMOVAL TOOL SHOULD REST) IS SNAPPED OFF]. THIS COMPLAINT IS NOT RELATED TO A CASE OR PATIENT INVOLVEMENT. IT WAS REPORTED THAT AN EVALUATION SET WAS USED FOR THE IN-SERVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50725 BLADE 120MM RETRACTOR GAD SYNTHES HAGENDORF 8173644

    Patients

    Seq Age Sex Outcome Treatment
    1