BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS

    MDR report key: 11059433 · Received December 22, 2020

    Report

    Report Number
    8030965-2020-09925
    Event Type
    Injury
    Date Received
    December 22, 2020
    Report Date
    December 2, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K103002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. H10 ADDITIONAL NARRATIVE: PART: 04.005.430, LOT: L961529, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: JULY 4, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE SCREWS WERE FOUND BROKEN AT THE SHAFT AND THE THREAD FLANKS ARE FLATTENED. THERE ARE SEVERAL MECHANICAL DAMAGES VISIBLE ON THE ENTIRE SURFACE OF BOTH DEVICES. THE ANODIZED LAYER IS WORN AWAY AT THE DAMAGES WHICH INDICATES THAT THEY WERE CAUSED POST-MANUFACTURING. THE OBSERVED DAMAGE IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION AS SUCH THE COMPLAINT CONDITION CAN BE CONFIRMED. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. DIMENSIONAL INSPECTION: A DIMENSIONAL TEST IS NOT APPROPRIATE, SINCE ALL COMPLAINT-RELEVANT DIMENSIONS CAN NO LONGER CORRESPOND TO THE VALID TECHNICAL DRAWINGS SPECIFICATIONS DUE TO THE DAMAGE INCURRED. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FURTHERMORE, AS INDICATED IN THE MANUFACTURING DOCUMENTS, THE CORRECT MATERIAL (TAN/TI6AL7NB) WAS USED ACCORDING ISO 5832-11 CONCLUSION: OUR INVESTIGATION HAS SHOWN THAT THE COMPLAINT CONDITION FOR THE BROKEN SCREWS CAN BE CONFIRMED. BECAUSE OF THE DAMAGE, IT IS NOT POSSIBLE TO MEASURE THE RELEVANT DIMENSION. THIS DAMAGE IS CLEARLY CAUSED POST MANUFACTURING. THIS LOT WAS MANUFACTURED IN JULY 2018, ALL DEVICES ARE DISTRIBUTED AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS PART- AND LOT NUMBER COMBINATION. THIS AND THE FINDINGS ABOVE LET US EXCLUDE A MANUFACTURING RELATED ISSUE. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS BREAKAGE. WE CAN ONLY ASSUME THAT ANY OCCURRENCE DURING THE HEALING PROCESS, E.G. NON-UNION, DELAYED UNION, MAL-UNION, OVERLOADING OF THE OSTEOSYNTHESIS OR A COMBINATION OF DIFFERENT FACTORS, DID LEAD TO A FATIGUE FAILURE. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION OPERATION FOR THE FIXATION OF AN UNHEALED FRACTURE. THE PATIENT WAS INITIALLY OPERATED ON (B)(6) 2020 FOR THE FIXATION OF A TIBIA SHAFT FRACTURE WITH AN EXPERT TIBIA NAIL. ON (B)(6) 2020 THE PATIENT'S X-RAY SHOWED THAT THE DISTAL TWO (2) LOCKING BOLTS WERE BROKEN. THERE WERE TWO (2) DISTAL AND TWO (2) PROXIMAL BOLTS IMPLANTED. DURING THE REVISION PROCEDURE THE NAIL AND BOLTS WERE EXPLANTED AND A PLATE WAS IMPLANTED. CONCOMITANT DEVICES: EXPERT TN Ø9 CANN L420 TAN DBLUE (PART# 04.004.364; LOT# 1L11553; QUANTITY: 1). EXPERT END CAP F/TIBNAILS Ø8-13 EXTENS. (PART:04.004.000; LOT #: L765416; QUANTITY: 1). LOCKING SCREW (PART: 04.005.442; LOT#: L730761, QUANTITY: 1). LOCKING SCREW (PART: 04.005.450; LOT#: L740632, QUANTITY: 2). THIS REPORT IS FOR ONE (1) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525178 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH L691529

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPERT END CAP F/TIBNAILS Ø8-13 EXTENS.| EXPERT TN Ø9 CANN L420 TAN DBLUE| LOCKSCR Ø4 L50 F/NAILS TAN| LOCKSCR Ø4 L52 F/NAILS TAN DBLUE| LOCKSCR Ø4 L60 F/NAILS TAN DBLUE