BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDING MECHANISM

    MDR report key: 5919126 · Received August 31, 2016

    Report

    Report Number
    9612488-2016-10357
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    August 16, 2016
    Report Date
    August 17, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT INVESTIGATION: PER THE TECHNIQUE GUIDE, THIS DEVICE IS USED IN CONJUNCTION WITH AN ATTACHMENT ARM TO CONSTRUCT THE COLLINEAR REDUCTION CLAMP. THIS CLAMP IS INTENDED TO ASSIST IN ACHIEVING AND MAINTAINING FRACTURE REDUCTION IN MINIMALLY INVASIVE TECHNIQUES. A REVIEW OF THE CURRENT DESIGN DRAWING /MANUFACTURED REVISION FOR THE TOP LEVEL ASSEMBLY AND THE HANDLE COMPONENT DRAWING WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. HOWEVER, THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH EXCESSIVE LOADING AND/OR ROUGH HANDLING. THE APPLIED FORCE DURING USE LIKELY PERMITTED FINAL SEPARATION. 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. (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE AND REPAIR HISTORY REVIEW WAS ATTEMPTED FOR THIS DEVICE; HOWEVER, IT COULD NOT BE COMPLETED AS THE DEVICE IS A LOT/BATCH CONTROLLED ITEM. THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS ATTEMPTED FOR THE SUBJECT DEVICE LOT NUMBER. MANUFACTURING LOCATION: (B)(4); SUPPLIER: (B)(4) (SUPPLIER LOT NUMBER 2142673). DATE OF MANUFACTURE: AUG 29, 2005. THE REVIEW SHOWED THAT THE DEVICE IS OLDER THAN 15 YEARS AND AT THIS TIME, MANUFACTURING DOCUMENTS FOR INSTRUMENTS WERE ONLY RETAINED FOR 10 YEARS PER THE SOP WHICH WAS IN PLACE UNTIL AUGUST 2014. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS UNDERGOING EVALUATION. THE EVALUATION RESULTS ARE PENDING COMPLETION. 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

    ADDITIONAL NARRATIVE: A SERVICE HISTORY EVALUATION/REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE CUSTOMER REPORTED THE HANDLE BROKE OFF. THE REPAIR TECHNICIAN REPORTED THE HANDLE WAS BROKEN, AND BOTH SLIDING MECHANISMS WERE MISSING. HANDLE CRACKED/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. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: ONE SLIDING MECHANISM (PART NUMBER 314.291, LOT NUMBER 5087583) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF "BROKEN: INTRAOPERATIVELY." IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A DISTAL FEMUR ON (B)(6) 2016 WHILE THE SURGEON WAS REDUCING THE FRACTURE UPON SQUEEZING, THE BLACK HANDLE BROKE OFF THE SLIDING MECHANISM FROM A COLLINEAR REDUCTION CLAMP. THE HANDLE BROKE IN TWO PIECES FAR FROM THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A STANDARD REDUCTION FORCEPS WITH TWO (2) MINUTES SURGICAL DELAY. NO FRAGMENTS WERE GENERATED AND PATIENT/STATUS WAS REPORTED AS STABLE AFTER THE PROCEDURE. THE COMPLAINT CONDITION IS CONFIRMED AS THE DEVICE WAS RECEIVED WITH THE BLACK HANDLE BROKEN. THE BREAK IS ROUGHLY TRANSVERSE AND LOCATED AT THE INFERIOR SCREW. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, FUNCTIONAL TEST, DRAWING REVIEW, COMPLAINT HISTORY REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE DEVICE WAS RECEIVED WITH THE BLACK HANDLE BROKEN. THE BREAK IS ROUGHLY TRANSVERSE AND LOCATED AT THE INFERIOR SCREW. THE BROKEN PIECES ALIGN SUCH THAT NO MISSING PORTIONS WERE OBSERVED. A DENT WAS NOTED ON THE DISTAL PORTION OF THE SHAFT. THE TWO BLACK STERILIZATION WINDOWS WERE NOT RETURNED. THE BALANCE OF THE DEVICE SHOWS SURFACE WEAR CONSISTED WITH USE AND IS IN WORKING CONDITION. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED AND THE RISK ASSESSMENT WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. THE CALCULATED OCCURRENCE RATE IS ACCEPTABLE UNDER THE SYSTEM RISK ASSESSMENT. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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.

    Description of Event or Problem · 1

    CONCOMITANT DEVICE: ARM (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR ON (B)(6) 2016, WHILE THE SURGEON WAS REDUCING THE FRACTURE UPON SQUEEZING, THE BLACK HANDLE BROKE OFF THE SLIDING MECHANISM FROM A COLLINEAR REDUCTION CLAMP. THE HANDLE BROKE IN TWO PIECES FAR FROM THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A STANDARD REDUCTION FORCEPS WITH TWO (2) MINUTES SURGICAL DELAY. NO FRAGMENTS WERE GENERATED AND PATIENT'S STATUS WAS REPORTED AS STABLE AFTER THE PROCEDURE. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570407 SLIDING MECHANISM FORCEPS HTD SYNTHES BETTLACH 5087583

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR