BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM TI CANCELLOUS LOCKING SCREW 39MM THRD LENGTH

    MDR report key: 9136918 · Received September 30, 2019

    Report

    Report Number
    8030965-2019-68863
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 3, 2019
    Report Date
    September 3, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KWQ
    UDI-DI
    07611819790155
    PMA / PMN Number
    K022791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    NURSE

    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. INVESTIGATION SUMMARY PICTURE REVIEW: NARRATIVE (SCREW RECESS ROUNDED) COULD BE VERIFIED FROM PROVIDED PICTURES INVESTIGATION SITE: (B)(6). SELECTED FLOW: DAMAGE: WORN/STRIPPED. VISUAL INSPECTION: ONE CANCELLOUS LOCKING SCREW WAS RETURNED FOR EVALUATION. THE VISUAL INSPECTION CONFIRMED THAT THE HEXAGONAL SCREW RECESS IS BADLY DAMAGED, E.G. ROUNDED. THE THREAD FLANKS AT THE SCREW HEAD AND SCREW SHAFT ARE FLATTENED INDICATING THAT THE SCREW WAS IMPLANTED. DIMENSIONAL INSPECTION: THE RELEVANT DIMENSIONS OF THE SCREW SHAFT COULD NOT BE CHECKED DUE TO THE DAMAGE INCURRED. DOCUMENT / SPECIFICATION REVIEW: THE CERTIFICATE OF THE RAW MATERIAL WAS REVIEWED DURING THE PERFORMED DEVICE HISTORY REVIEW AND MET SPECIFICATION. THE CANCELLOUS BONE SCREW IS MADE FROM TITANIUM ALLOY (TI AL6 NB7 ) PER ISO 58632-11. SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS THE RETURNED CANCELLOUS BONE SCREW PRESENTS HEAVY DAMAGE AT THE SCREW RECESS. THE WEAR OF THE THREAD FLANKS IS CONSISTENT WITH USE. THIS PRODUCTION LOT (H707256) WAS MANUFACTURED IN OCTOBER 2018 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THE INVESTIGATION FOUND NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIAS. THE DAMAGED HEXAGONAL RECESS IS A CLEAR INDICATION FOR HIGH APPLIED FORCES DURING SCREW INSERTION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: PART NUMBER: 489.162. LOT NUMBER: H707256. SUPPLIER LOT NUMBER: N/A. MANUFACTURE DATE OR RELEASE TO WAREHOUSE DATE: 08/10/2018. EXPIRATION DATE: N/A. SUPPLIER/MANUFACTURE SITE: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION OF LOT NUMBER H707256. 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. RAW MATERIALS REVIEW: NO NCRS WERE GENERATED DURING PROCESSING OF RAW MATERIAL LOT NUMBER H540461, THE MATERIAL USED FOR THE MANUFACTURE OF PRODUCT LOT # H707256. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE PROCESSING OF THE MATERIAL THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS 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.

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD 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 AT THE END OF CORPECTOMY SURGERY WHEN THE TSLP PLATE WAS USED TO STABILIZE INSERTED EXPANDABLE CORPECTOMY DEVICE, CANCELLOUS LOCKING SCREW (489.162 - DIAMETER 5,5 MM, SELF-TAPPING, TITANIUM ALLOY) WAS INSERTED INTO THE PLATE. DURING INSERTION SCREW DRIVER WAS TURNING IN HEXAGONAL HEAD OF THE SCREW AND IT WAS IMPOSSIBLE TO INSERT THE SCREW. SCREW DRIVER WAS CORRECTLY INSERTED ONTO THE CREW HEAD, BUT SCREW DRIVE COULD NOT LEAN ON THE NOTCHES OF THE HEXAGONAL PART OF THE SCREW HEAD, AS THE MATERIAL WAS SO SOFT THAT HEXAGONAL SHAPE OF THE CREW HEAD ALMOST DISAPPEARED. SURGERY WAS DELAYED FOR ONLY APPROXIMATELY 2 MINUTES AND AN ALTERNATIVE SCREW WAS USED TO COMPLETE THE SURGERY. NEW SCREW WAS WORKING FINE. NO CONSEQUENCE ON PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE: THORACOLUMBAR LOCKING TSLP (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1). UNKNOWN SCREWDRIVER SHAFT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1). 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
    928090 5.5MM TI CANCELLOUS LOCKING SCREW 39MM THRD LENGTH APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ OBERDORF SYNTHES PRODUKTIONS GMBH H707256 07611819790155

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - PLATES: THORACOLUMBAR SPINE LOCKING PLATE| UNK - SCREWDRIVERS: SHAFTS