BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARDRIVE SCREWDRIVER SHAFT QC/T15

    MDR report key: 8497632 · Received April 9, 2019

    Report

    Report Number
    8030965-2019-62642
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    March 18, 2019
    Report Date
    March 18, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    07611819740877
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: INITIAL REPORTER NAME AND ADDRESS, INITIAL REPORTER OCCUPATION: ADDITIONAL INFORMATION PROVIDED. DEVICE EVALUATED BY MFR: PART: 314.116; SYNTHES LOT: H082510; SUPPLIER LOT: H082510; RELEASE TO WAREHOUSE DATE: AUGUST 10, 2016; MANUFACTURING SITE: (B)(4).; SUPPLIER: (B)(4). NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE SCREWDRIVER IS BROKEN APPROXIMATELY 2MM FROM THE TIP SECTION AND IS BADLY TWISTED IN THE DIRECTION OF SCREW REMOVAL. THE BROKEN OFF PORTION IS MISSING. DIMENSIONAL INSPECTION: BECAUSE OF THE DAMAGES, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS. DRAWING/SPECIFICATION REVIEW: THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE, THEREFORE NO DRAWING/SPECIFICATION REVIEW IS NEEDED. MATERIAL REVIEW: THE RAW MATERIAL CERTIFICATE WAS CHECKED AND FULFILLED THE SPECIFICATIONS. THE FRACTURE SURFACE SHOWS THE TYPICAL VIEW OF A TORSION FRACTURE. SUMMARY: THE RECEIVED CONDITION OF THE DEVICE IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. THE DAMAGE AT THE TIP INDICATES THAT A MECHANICAL OVERLOADING SITUATION DURING SCREW REMOVAL IS MOST PROBABLY THE REASON FOR THE BREAKAGE AND DEFORMATION OF THE TIP. THE VISIBLE DAMAGES ARE NOT FROM ANY MANUFACTURING NON-CONFORMITY. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. CORRECTED DATA: 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 · 0

    REPORTER IS SYNTHES SALES CONSULTANT. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE INCORRECT G4 DATE WAS INADVERTENTLY UTILIZED IN INITIAL MEDWATCH. THE CORRECT DATE IS MARCH 18, 2019.  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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. SURGICAL INTERVENTION THE SURGEON USED AN UNKNOWN CARBIDE DRILL TO SUCCESSFULLY EXTRACT THE SCREW. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 A REMOVAL SURGERY. ORIGINALLY, AN UNKNOWN LOCKING COMPRESSION PLATE (LCP) MEDIAL PROXIMAL TIBIAL PLATE WAS IMPLANTED ON AN UNKNOWN DATE. DURING THE REMOVAL, THE SURGEON USED AN UNKNOWN POWER TOOL TO EXTRACT AN UNKNOWN LOCKING SCREW, BUT THE TOOL HAD BEEN SET CONVERSELY AND THE SCREW WAS INSERTED EXCESSIVELY INTO THE SCREW HOLE. HOWEVER, WHEN THE SURGEON TRIED TO REMOVE THE SCREW WITH THE STARDRIVE SCREWDRIVER SHAFT, THE SHAFT BROKE OFF. THUS, THE SURGEON USED AN UNKNOWN CARBIDE DRILL TO SUCCESSFULLY EXTRACT THE SCREW. THERE WERE NO PIECES LEFT IN THE PATIENT¿S BODY. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LCP MEDIAL PROXIMAL TIBIAL PLATE ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288913 STARDRIVE SCREWDRIVER SHAFT QC/T15 SCREWDRIVERS HXX OBERDORF SYNTHES PRODUKTIONS GMBH H082510 07611819740877

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE EVENT DESCRIPTION