BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM/2.5MM DOUBLE DRILL SLEEVE

    MDR report key: 6881270 · Received September 20, 2017

    Report

    Report Number
    1719045-2017-10961
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    August 4, 2017
    Report Date
    August 30, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    UDI-DI
    10886982187703
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: THE CUSTOMER REPORTED THE DRILL GUIDE WAS MISSHAPEN AND ONE SIDE APPEARED TO BE CRUSHED. THE REPAIR TECHNICIAN REPORTED THE SLEEVE ON THE 2.5MM SIDE WAS CRUSHED, AND THE TIP APPEARED TO BE BROKEN AND MISSING. TIP BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. DHR REVIEW FOR PART # 312.28 SYNTHES LOT # 4350179 SUPPLIER LOT # 2011484, RELEASE TO WAREHOUSE DATE: 03 DEC 2001, EXPIRATION DATE: NA, SUPPLIER: (B)(4). NO NCR'S 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. THE DEVICE WAS RECEIVED AND A PD INVESTIGATION WAS COMPLETED. THE DEVICE WAS RECEIVED AND A PD INVESTIGATION WAS COMPLETED. THE 312.28, LOT NUMBER 2011484, 3.5MM/2.5MM DOUBLE DRILL SLEEVE WAS RETURNED WITH A MALFORMED 2.5 MM DRILL GUIDE TIP. THE TEETH OF THE 2.5 MM DRILL GUIDE TIP ARE BENT INWARDS TOWARDS THE CENTER OF AXIS OF THE DRILL GUIDE AND CHIPPED, FRAGMENT(S) OF THE TIP IS MISSING. THE CUSTOMER REPORTED THE DRILL GUIDE WAS MISSHAPEN AND ONE SIDE APPEARED TO BE CRUSHED. THE REPAIR TECHNICIAN REPORTED THE SLEEVE ON THE 2.5MM SIDE WAS CRUSHED, AND THE TIP APPEARED TO BE BROKEN AND MISSING. TIP BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WAS FORWARDED TO CUSTOMER QUALITY. THIS COMPLAINT IS CONFIRMED. A VISUAL INSPECTION, DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICES ARE ALREADY BROKEN/MALFORMED. CQ INVESTIGATION PART #312.28 LOT #2011484 3.5MM/2.5MM DOUBLE DRILL SLEEVE. THE DEVICE WAS RETURNED AND IT WAS REPORTED THAT "A DRILL GUIDE WAS FOUND MISSHAPEN. IT APPEARED THAT ONE SIDE OF IT HAD BEEN CRUSHED" THIS CONDITION IS CONFIRMED; THE INSTRUMENT WAS RETURNED WITH A MALFORMED 2.5 MM DRILL GUIDE TIP. THE TEETH OF THE 2.5 MM DRILL GUIDE TIP ARE BENT INWARDS TOWARDS THE CENTER OF AXIS OF THE DRILL GUIDE AND CHIPPED, FRAGMENT(S) OF THE TIP IS MISSING. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO ROUGH HANDLING DURING SURGERY/STERILE PROCESSING AND/OR CUMULATIVE WEAR OVER THE PART'S LIFETIME. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DRILL GUIDE WAS FOUND MISSHAPEN. IT APPEARED THAT ONE SIDE OF IT HAD BEEN CRUSHED; IT WAS NO LONGER A CIRCLE, BUT AN OVAL. THIS WAS DISCOVERED BEFORE A PROXIMAL HUMERUS OPEN REDUCTION INTERNAL FIXATION (ORIF) ON (B)(6) 2017, BEFORE THE PATIENT ENTERED THE ROOM. ANOTHER INSTRUMENT WAS AVAILABLE FOR USE AND THERE WAS NO IMPACT ON THE UPCOMING CASE. SUBSEQUENTLY, ONE OF THE ENDS (ONE OF THE TINES) BROKE OFF OF REDUCTION FORCEPS DURING THIS CASE. WHILE THE SURGEON WAS USING THE CLAMP TO REDUCE THE FRACTURE, ONE OF THE ENDS BROKE OFF. THE SURGEON REMOVED THE BROKEN PIECE FROM THE SURGICAL FIELD, AND CONTINUED ON WITH THE REDUCTION. ANOTHER INSTRUMENT WAS AVAILABLE FOR USE. THERE WAS A SURGICAL DELAY OF A FEW SECONDS. NO FRAGMENTS REMAINED IN THE PATIENT. NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT IS FOR TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659107 3.5MM/2.5MM DOUBLE DRILL SLEEVE GUIDE FZX SYNTHES MONUMENT 2011484 10886982187703

    Patients

    Seq Age Sex Outcome Treatment
    1