BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING FORCEPS 170MM

    MDR report key: 6014125 · Received October 10, 2016

    Report

    Report Number
    3009417901-2016-10038
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE INVESTIGATION OF THE COMPLAINED HOLDING FORCEPS HAS SHOWN THAT ALL THREE HOLDING FORCEPS ARE BADLY DAMAGED AT THE AREA OF THE FORCEPS MOUTH; LOT 5936982 A SMALL PART OF THE PLATE IS BROKEN OFF AND THE SHEET IS DEFORMED/WIDENED, LOT 5931646 ONE PRONG IS BROKEN OFF (BROKEN OFF PART NOT RETURNED) AND SHEET DEFORMED/WIDENED, LOT 5933650 ONE PRONG IS BROKEN OFF (BROKEN OFF PART RETURNED). THE REVIEW OF THE PRODUCTION HISTORIES REVEALED THAT THESE INSTRUMENTS WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE ARTICLE 391.800 FROM THE LOT 5931646 HAS BEEN MANUFACTURED ON 27-JAN-2015. THE INVESTIGATION OF THE DHR SHOWS NO IRREGULARITIES. THE INVESTIGATION SHOWED THAT THE FORCEPS MOUTH IS BROKEN AND DEFORMED. THIS KIND OF DEFORMATION CANNOT HAPPEN AT THE MANUFACTURING AND/OR TRANSPORT PROCESS. THE COMPLAINT IS CONFIRMED BUT NOT VALID FROM THE MANUFACTURING STANDPOINT. THE PARTS RETURNED HAVE BEEN RE-INSPECTED FOR THE FEATURES RELEVANT TO THE COMPLAINT CONDITION AND WERE FOUND TO COMPLY WITH THE SPECIFICATIONS. ALSO THE HARDNESS PARAMETERS WERE CHECKED AND FOUND TO BE GOOD. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED, THIS COMPLAINT CONDITION IS LIKELY A RESULT OF METHOD OF USE / MECHANICAL OVERLOAD; THE COMPLAINT IS DETERMINED NOT TO BE A RESULT OF A DETECTED PRODUCT RELATED DEFICIENCY. 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. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INITIAL REPORTER PHONE#: (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. 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. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THREE HOLDING FORCEPS 170MM BROKE WHILE TWISTING CERCLAGE WIRES WITH MINIMAL EFFORT, DURING SURGERY ON (B)(6) 2016. NO MEDICAL INTERVENTION WAS NEEDED. SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. IT IS UNKNOWN IF PIECES OF THE INSTRUMENTS REMAIN IN THE PATIENT AFTER SURGERY. CONCOMITANT DEVICES REPORTED: CERCLAGE WIRES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS IS REPORT NUMBER 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666423 HOLDING FORCEPS 170MM FORCEPS HTD SYNTHES SALZBURG 5931646

    Patients

    Seq Age Sex Outcome Treatment
    1 CERCLAGE WIRES