BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.0MM CABLE WITH CRIMP 750MM-STERILE

    MDR report key: 5471173 · Received March 1, 2016

    Report

    Report Number
    1719045-2016-10180
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 12, 2016
    Report Date
    February 12, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    PMA / PMN Number
    PK992616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT INFORMATION: PATIENT HEIGHT REPORTED AS (B)(6). PATIENT INITIALS ARE (B)(6). AT THIS TIME, IT IS UNKNOWN WHICH CABLE WIRE BROKE. THE FOLLOWING REPRESENT THE POTENTIAL LOTS AND THE ASSOCIATED UDI NUMBERS: LOT P200278: (B)(4), LOT P197038: (B)(4), LOT P201160: (B)(4). DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED FOR EACH OF THE THREE (3) POTENTIAL LOT NUMBERS WITH RESULTS AS FOLLOWS: LOT P200278 ¿ MANUFACTURING DATES: JANUARY 27, 2015, FEBRUARY 25, 2015, AND MARCH 25, 2015 PACKAGED BY: (B)(4). EXPIRATION DATE: NOVEMBER 30, 2019. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. LOT P197038 - MANUFACTURING DATES: DECEMBER 12, 2014 AND DECEMBER 22, 2014. PACKAGED BY: (B)(4). EXPIRATION DATE: OCTOBER 30, 2019. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. LOT P201160 - MANUFACTURING DATES: MARCH 25, 2015 AND APRIL 2, 2015. PACKAGED BY: (B)(4). EXPIRATION DATE: DECEMBER 30, 2019. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 EVALUATION: A VISUAL INSPECTION CAPTURED THE BROKEN CABLE. IT IS LIKELY THAT APPLYING MORE THAN 40KG OF TENSION TO THE 1.0MM CABLE MAY HAVE CAUSED THE FRAYING OR BREAKAGE OF THE CABLE. A REVIEW OF PAST OCCURRENCES HAS DETERMINED THIS TO BE THE ONLY OCCURRENCE RELATED TO CABLE FRACTURE WHILE TENSIONING. NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED AND/OR CONFIRMED. PRODUCT INVESTIGATION SUMMARY: THE RETURNED CABLE IS A COMPONENT OF THE ORTHOPAEDIC CABLE SYSTEM. DURING USE, THE CABLE IS PASSED AROUND THE BONE WITH A CABLE PASSER AND THEN TENSIONED. THE SYSTEM TECHNIQUE GUIDE NOTES THAT THE APPLICATION OF FORCE IN EXCESS OF 40KG CAN LEAD TO FRAYING OR BREAKAGE. THE RELEVANT DRAWINGS FOR THE RETURNED IMPLANT WERE REVIEWED. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CLARIFICATION: THE PRODUCT LOT WAS RELEASED IN TWO (2) BATCHES ON SEPARATE DATES: MARCH 25, 2015 AND APRIL 2, 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

    CABLE WIRE VERIFIED, DHR IS FOR LOT #P201160. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE DHR REVIEW FOR PART# 298.800.01S LOT# P201160 RELEASE TO WAREHOUSE DATE: 25MAR2015, SUPPLIER: RTI SURGICAL, PACKAGED BY: SYNTHES - (B)(4), EXPIRATION DATE:30DEC2019. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT DISTRIBUTED IN TWO BATCHES ON 25MAR2015 AND 02APR2015. 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

    (B)(4). 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 A CABLE WIRE BROKE AS IT WAS BEING TIGHTENED WITH A CABLE TENSIONER DURING A PERI-PROSTHETIC HUMERUS PROCEDURE ON (B)(6) 2016. THE WIRE BROKE WHERE THE CABLE WIRE MEETS THE CABLE TENSIONER, BUT THE WIRE DID NOT REMAIN IN THE TENSIONER. INSTEAD, THE BROKEN CABLE WIRE WAS EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION AND THE PROCEDURE WAS COMPLETED USING DIFFERENT, READILY AVAILABLE INSTRUMENTS. THE SURGERY WAS COMPLETED WITH A FIVE (5) MINUTE SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127363 1.0MM CABLE WITH CRIMP 750MM-STERILE CERCLAGE FIXATION JDQ SYNTHES MONUMENT P201160

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR