BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 85MM-STERILE

    MDR report key: 6455726 · Received April 4, 2017

    Report

    Report Number
    1000562954-2017-10037
    Event Type
    Injury
    Date Received
    April 4, 2017
    Report Date
    March 14, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HSB
    PMA / PMN Number
    K040336
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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

    PATIENT DATE OF BIRTH WAS PROVIDED. 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

    (B)(4). A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (6.5MM TI RECON SCREW WITH T25 STARDRIVE 85MM-STERILE, PART NUMBER 04.003.027S, LOT NUMBER L010341). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: RECEIVED CONDITION BOTH HIP SCREWS 04.003.027S ARE BROKEN AT THE SAME SHAFT AREA APPROXIMATELY 30 MM BENEATH THE SCREW HEADS. BOTH HIP SCREWS SHOW VARIOUS STRIATIONS AND ABRADED COLOR MARKS ON ENTIRE SHAFTS BUT ESPECIALLY AT THE CONTACT AREAS OF NAIL BORES. THE ANODIZED COLOR IS GOLDEN AND THE VISIBLE ARTICLE AND LOT NUMBER ETCH MATCHES WITH REPORTED ARTICLES. DIMENSION BOTH HIP SCREW SHAFTS DIAMETERS WERE CHECKED FOR DIMENSIONS ACCURACY REFERRING TO TECHNICAL DRAWING. TARGET DIMENSION OF RECON SCREW SHAFT DIAMETER LOT L166083 IS 6.47 +/-0.05 MM. ACTUAL DIMENSION OF RECON SCREW SHAFT DIAMETER LOT L166083 IS 6.46 MM / PASS. TARGET DIMENSION OF RECON SCREW SHAFT DIAMETER LOT L010341 IS 6.47 +/-0.05 MM. ACTUAL DIMENSION OF RECON SCREW SHAFT DIAMETER LOT L010341 IS 6.46 MM / PASS. MATERIAL AND MANUFACTURING: THE EXAMINATION OF THE MANUFACTURING PAPERS AND THE RAW-MATERIAL TESTING CERTIFICATES SHOWED NO DEVIATIONS REGARDING DIMENSIONS, MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARDS FOR TITANIUM TAN ISO 5832-11. CONCOMITANTS DEVICES: EXPERT¿ A2FN, NAIL, (PART#04.009.353S / LOT# L126156 / QUANTITY 1): THE NAIL IS INTACT BUT SHOWING FRETTING MARKS AT THE PROXIMAL BOLT FIXATION AREA. THIS MIGHT BE A RESULT FROM FRICTION AGAINST THE BONE AND IS A SIGN FOR INSTABILITY AND MICRO MOVEMENTS OF THE IMPLANT. END-CAP F/A2FN (PART# 04.009.000S / LOT# 9817162 / QUANTITY 1): THE END-CAP IS INTACT AND FULLY FUNCTIONAL. LOCKING SCREW Ø5 L34 F/NAILS (PART# 04.005.524 / LOT# L122248 / QUANTITY 1): BESIDE SOME WEAR THE LOCKING SCREW IS INTACT. LOCKING SCREW Ø5 L34 F/NAILS (PART# 04.005.524 / LOT# L004874 / QUANTITY 1): BESIDE SOME WEAR THE LOCKING SCREW IS INTACT. CONCLUSION: BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS BREAKAGE. THE EXISTING FRETTING MARKS ON THE NAIL AND ON BOTH HIP SCREWS ARE A SIGN FOR INSTABILITY AND MICRO MOVEMENTS OF THE IMPLANTS. WE CAN ONLY ASSUME THAT ANY OCCURRENCE DURING THE HEALING PROCESS, E.G. NON-UNION, DELAYED UNION, OVERLOADING OR A COMBINATION OF DIFFERENT FACTORS, DID LEAD TO A FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT AND INSTABILITY OF THE FRACTURE SITUATION MAY HAVE PLAYED A CERTAIN ROLE, TOO. NEITHER A MANUFACTURING NOR A MATERIAL RELATED FAULT WAS IDENTIFIED. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS BREAKAGE. THE EXISTING FRETTING MARKS ON THE NAIL AND ON BOTH HIP SCREWS ARE A SIGN FOR INSTABILITY AND MICRO MOVEMENTS OF THE IMPLANTS. WE CAN ONLY ASSUME THAT ANY OCCURRENCE DURING THE HEALING PROCESS, E.G. NON-UNION, DELAYED UNION, OVERLOADING OR A COMBINATION OF DIFFERENT FACTORS, DID LEAD TO A FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT AND INSTABILITY OF THE FRACTURE SITUATION MAY HAVE PLAYED A CERTAIN ROLE, TOO. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER NUMBER IS (B)(6). PATIENT AGE AT TIME OF EVENT AND/OR DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. OTHER NUMBER¿UDI: (B)(4). THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. INITIAL REPORTING FACILITY PHONE NUMBER IS (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED SUBJECT DEVICE LOT. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: JUNE 7, 2016. EXPIRATION DATE: MAY 1, 2026. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT LOT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. (B)(4). 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

    CONCOMITANT MEDICAL PRODUCTS: END-CAP F/A2FN CANN EXTENS (PART# 04.009.000S / LOT# 9817162 / QUANTITY 1); LOCKSCR Ø5 L34 F/NAILS (PART# 04.005.524 / LOT# L122248 / QUANTITY 1); LOCKSCR Ø5 L34 F/NAILS (PART# 04.005.524 / LOT# L004874 / QUANTITY 1).

    Description of Event or Problem · 1

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 DUE TO TWO (2) 6.5MM RECONSTRUCTION SCREWS THAT HAD BROKEN POSTOPERATIVELY. THE PATIENT WAS INITIALLY IMPLANTED WITH THE REPORTED SCREWS, ONE (1) EXPERT¿ A2FN NAIL, AND AN UNKNOWN QUANTITY OF UNKNOWN DISTAL SCREWS ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT WAS WELL, AND HAD RESUMED NORMAL WEIGHT BEARING WITH NO REPORTS OF INFECTION. ON (B)(6) 2017 THE PATIENT REPORTED, ONE TO TWO WEEKS PREVIOUSLY, HE WAS WALKING AND FELT A SUDDEN SHARP PAIN AT THE HIP. THE PATIENT DENIED ANY FALLS AND CLAIMED HE WAS COMPLIANT WITH THE SURGEON¿S POSTOPERATIVE INSTRUCTIONS. X-RAY SHOWED THAT BOTH HIP SCREWS WERE BROKEN. THE PATIENT WAS SCHEDULED FOR A2FN AND SCREW REMOVAL, OPEN REDUCTION INTERNAL FIXATION AND IMPLANTATION WITH A DYNAMIC CONDYLAR SCREW SYSTEM ON (B)(6) 2017. THE PATIENT¿S POSTOPERATIVE STATUS WAS REPORTEDLY STABLE. CONCOMITANT PARTS: EXPERT¿ A2FN, NAIL, (PART#04.009.353S / LOT# L126156 / QUANTITY 1). DISTAL LOCKING SCREWS (PART# UNKNOWN / LOT# UNKNOWN / QUANTITY UNKNOWN). THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239560 6.5MM TI RECON SCREW WITH T25 STARDRIVE 85MM-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MEZZOVICO L010341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN DISTAL LOCKING SCREWS, QUANTITY UNKNOWN