BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.7MM & SMALL SCREWS

    MDR report key: 9181218 · Received October 11, 2019

    Report

    Report Number
    8030965-2019-69274
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 25, 2019
    Report Date
    September 25, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTJ
    UDI-DI
    07611819020733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: DEVICE HISTORY LOT PART #: 319.010, LOT #: 2100618, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 07. JULY 2004. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: INVESTIGATION SUMMARY INVESTIGATION SITE: CQ ZUCHWIL. SELECTED FLOW: DEVICE INTERACTION - JAMMED. VISUAL INSPECTION: THE DEPTH GAUGE WAS RECEIVED WITH THE REPORTED CONDITION OF ROUGH RUNNING. THE MEASURING TIP PRESENTS SIGNS OF USE. BESIDES, THE INSTRUMENT IS VISUALLY IN GOOD CONDITION. FUNCTIONAL TEST FUNCTIONAL TEST WAS PERFORMED, AND THE REPORTED COMPLAINT CONDITION COULD BE CONFIRMED - THE SLIDER IS ROUGH RUNNING. DURING THE INVESTIGATION THE INSTRUMENT WAS LUBRICATED WITH SYNTHES SPECIAL OIL AND WAS THEN FREELY MOVABLE AS REQUIRED. SUMMARY THE COMPLAINT CONDITION IS CONFIRMED AS THE DEPTH GAUGE IS ROUGH RUNNING. UPON DISASSEMBLING IT WAS NOTED THAT THE COMPLAINED DEPTH GAUGE 319.010 IS ASSEMBLED FROM COMPONENT PARTS THAT ORIGINALLY DID NOT BELONG TOGETHER - SLEEVE W/POSITION-PIN F/DEPTH GAUGE LOT 2100618 AND SCALE BODY 319.010.500 LOT 2762347. HOWEVER, THIS WOULD NOT AFFECT THE PROPER PERFORMANCE OF THE DEVICE. THE SLEEVE WAS MANUFACTURED IN JULY 2004 AND THE SCALE BODY WAS MANUFACTURED IN AUGUST 2011 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIAS AND THE MALFUNCTION COULD BE TRACED BACK TO AN INAPPROPRIATE REPROCESSING; OBVIOUSLY THE RECOMMENDED LUBRICATION AFTER THE CLEANING PROCESS WAS NOT CARRIED OUT PROPERLY. THE INSUFFICIENT LUBRICATION CAUSED THE BALL BEARING OF THE INSTRUMENT TO BECOME SEIZED UP. PLEASE NOTE, THE CLINICAL REPROCESSING INSTRUCTIONS (SE_023827) STATES THAT INSTRUMENTS WITH MOVING PARTS, SUCH AS HINGES AND JOINTS, SPRING-LOADED BALL BEARINGS, AND THREADED PARTS MUST BE LUBRICATED AFTER THE REPROCESSING. IT IS RECOMMENDED TO LUBRICATE AND MAINTAIN SYNTHES INSTRUMENTS WITH SYNTHES SPECIAL OIL ONLY. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THE ROOT CAUSE WAS IDENTIFIED DURING THE PERFORMED CQ EVALUATION AND THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. 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

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR DISTAL FIBULA FRACTURE WITH THE DEPTH GAUGE IN QUESTION. DURING THE SURGERY, THE DEPTH GAUGE DIDN¿T SLIDE WELL. IT DID NOT WORK WITH THE SALINE. SURGERY WAS SUCCESSFUL WITH ANOTHER DEPT GAUGE. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THIS IS REPORT 1 FOR 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976177 DEPTH GAUGE FOR 2.7MM & SMALL SCREWS GAUGE,DEPTH HTJ OBERDORF SYNTHES PRODUKTIONS GMBH 2100618 07611819020733

    Patients

    Seq Age Sex Outcome Treatment
    1