BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDING MECHANISM

    MDR report key: 5878411 · Received August 16, 2016

    Report

    Report Number
    2520274-2016-14107
    Event Type
    Malfunction
    Date Received
    August 16, 2016
    Date of Event
    July 28, 2016
    Report Date
    July 28, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S EXACT WEIGHT WAS REPORTED AS (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THAT THE HANDLE BROKE; THE REPAIR TECHNICIAN REPORTED THAT THE HANDLE WAS BROKEN AND THAT BOTH OF THE SCREENS WERE MISSING. HANDLE CRACKED/BROKEN IS THE REASON FOR REPAIR; HOWEVER, THE ITEM IS NOT REPAIRABLE, PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED FOR FURTHER INVESTIGATION. INVESTIGATION ON-GOING. SERVICE HISTORY RECORD REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART 314.291 WITH LOT 13-0748 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS JUNE 27, 2013. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE REQUESTED BASED UPON THE PROVIDED PART/LOT NUMBERS FOR THE DEVICE. 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

    PRODUCT INVESTIGATION WAS COMPLETED FOR PART NUMBER 314.291, LOT NUMBER 13-0748. ONE SLIDING MECHANISM (PART NUMBER 314.291, LOT NUMBER 13-0748) WAS RECEIVED. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. A DEVICE HISTORY RECORD REVIEW DETERMINED THAT THE DEVICE WAS MANUFACTURED IN (B)(4) ON 03-JUN-2013. NO NON CONFORMANCE REPORTS WERE GENERATED DURING THE 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. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THE DEVICE IS A LOT/BATCH CONTROLLED ITEM. SERVICE AND REPAIR (S&R) EVALUATION: THE DEVICE WAS INITIALLY EVALUATED AT SERVICE AND REPAIR WHERE THE REPAIR TECHNICIAN CONFIRMED THAT THE HANDLE WAS BROKEN. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. AFTER S&R THE DEVICE WAS FORWARDED TO CUSTOMER QUALITY FOR INVESTIGATION. 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. 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. TWO OF THE DISTAL TEETH APPEAR DENTED. 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. 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 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. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JUN 3, 2013. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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 PATIENT UNDERWENT A RETROGRADE NAILING AND OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE OF THE RIGHT OLECRANON ON (B)(6) 2016 FOLLOWING A BELOW THE KNEE AMPUTATION THAT RESULTED FROM A MOTORCYCLE ACCIDENT A FEW DAYS PRIOR. ACCORDING TO PROPER PROCEDURE, THE SURGEON USED A COLLINEAR DURING THE REDUCTION PROCESS OF THE RIGHT DISTAL FEMUR. UPON THE APPLICATION OF PRESSURE TO THE REDUCTION CLAMP, THE BLACK HANDLE OF THE SLIDING MECHANISM BROKE. THE CLAMP WAS REMOVED AND THE PROCEDURE COMPLETED WITHOUT DELAY OR FURTHER INCIDENT. THE PATIENT WAS, THEREAFTER, TENTATIVELY SCHEDULED TO UNDERGO ANOTHER ORIF PROCEDURE OF THE ACETABULUM ON (B)(6) 2016. THE COMPLETION AND OUTCOME OF THAT PROCEDURE IS UNKNOWN. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529835 SLIDING MECHANISM FORCEPS HTD SYNTHES SELZACH 13-0748

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR