BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 5782238 · Received July 11, 2016

    Report

    Report Number
    3003875359-2016-10408
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 17, 2016
    Report Date
    June 23, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE MANUFACTURER RECEIVED AN INSERTION HANDLE (PART: 03.010.045 / LOT: 1834911) AND AN AIMING ARM (PART: 03.010.097 / LOT: 2001877) FOR EVALUATION. THE ¿AS RECEIVED CONDITION¿ OF EACH DEVICE IS LISTED BELOW: 03.010.045: VISIBLE SCRATCHES WITH SIGNS OF HEAVY WEAR AND TEAR; SEVERAL TRACES OF HAMMER IMPACT ARE ALSO VISIBLE ON THE SURFACE. THE SLEEVE HOLDER IS MISSING; 03.010.097: VISIBLE SCRATCHES AND MARKS ON THE SURFACE. UNFORTUNATELY, THE MANUFACTURER CANNOT DETERMINE THE EXACT ROOT CAUSE OF THE COMPLAINED OCCURRENCE AS NO DETAILED CLINICAL INFORMATION WAS PROVIDED. ALSO, THE REPORTED EVENT COULD NOT BE REPRODUCED. THE MANUFACTURING REVIEW OF BOTH RECEIVED DEVICES SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO SPECIFICATIONS; THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SEVERAL DEMO INSTRUMENTS FROM OUR PRODUCT DEVELOPMENT WERE USED TO PERFORM A FUNCTIONAL CHECK OF THE RETURNED PARTS. THE DEVICES PASSED ALL THE FUNCTIONAL REQUIREMENTS SUCCESSFULLY; NO MISALIGNMENT ISSUE COULD BE IDENTIFIED. BASED ON THIS EVALUATION, THE CAUSE OF FAILURE COULD NOT BE LINKED TO ANY MANUFACTURING NON-CONFORMANCES. NO PRODUCT FAULT COULD BE DETECTED. 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

    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. 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

    THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INITIAL REPORTER PHONE NUMBER: (B)(6). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: MARCH 28, 2008. NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    CONCOMITANT DEVICE(S) REPORTED: SLEEVE (PART/LOT: UNKNOWN / QUANTITY: 1), LATERAL ENTRY FEMORAL NAIL (PART: 04.003.257S / LOT: 9863726 / QUANTITY: 1), 6.5MM RECON SCREW, 90MM (PART: 04.003.028S / LOT: 9644099 / QUANTITY: 1), 6.5MM RECON SCREW, 95MM (PART: 04.003.029S / LOT: 9580561 / QUANTITY: 1), 5.0MM LOCKING SCREW, 50MM (PART: 04.005.540S / LOT: 9896177 / QUANTITY: 1), AND 5.0MM LOCKING SCREW, 46MM (PART: 04.005.536S / LOT: 9808263 / QUANTITY: 1).

    Description of Event or Problem · 1

    CLARIFICATION AND ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 25, 2016 FURTHER REPORTING THAT THE REPORTED EVENT OCCURRED DURING A SURGICAL PROCEDURE. POSTOPERATIVE X-RAYS REVEALED THAT THE SCREW DID NOT GO THROUGH THE NAIL HOLE. REVISION SURGERY IS NOT PLANNED

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THEY COULD NOT POSITION THE SCREW CORRECTLY INSIDE THE NAIL WITH THE AIMING ARM AND INSERTION HANDLE. THE INSTRUMENTS WERE VEILED; THE BOLTS WERE NOT ALIGNED WITH THE NAIL. THE SCREW WAS THEREFORE NOT POSITIONED INSIDE THE NAIL. THIS OCCURRED WHEN THE DEVICES WERE BEING TESTED OUTSIDE OF THE OPERATING ROOM; THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: SLEEVE (PART AND LOT NUMBER UNKNOWN, QUANTITY 1); NAIL (PART AND LOT NUMBER UNKNOWN, QUANTITY 1; SCREW (PART AND LOT NUMBER UNKNOWN, QUANTITY 1). THE DEVICES WERE BEING TESTED OUTSIDE OF THE OPERATING ROOM DUE TO INTRA-OPERATIVE ISSUES WITH SIMILAR DEVICES. THE INTRA-OPERATIVE ISSUES ARE BEING CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435557 STANDARD INSERTION HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 1834911

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR UNKNOWN SCREW