BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 6325838 · Received February 13, 2017

    Report

    Report Number
    3000270450-2017-10042
    Event Type
    Injury
    Date Received
    February 13, 2017
    Date of Event
    January 6, 2017
    Report Date
    January 18, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDS
    PMA / PMN Number
    K072095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR TWO (2), UNKNOWN LOCKING SCREWS. PART AND LOT NUMBERS WERE NOT PROVIDED FOR REPORTING. OTHER NUMBER¿UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. ONE (1) EACH OF THE FOLLOWING SCREWS IS IMPLANTED IN THE PATIENT HOWEVER IT IS UNKNOWN WHICH OF THE SCREWS BROKE POSTOPERATIVELY (MANUFACTURING LOCATION-SYNTHES (B)(4)): 212.109S, LOT L091290, 3.5 MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 26 MM, COMMON NAME¿NAIL, FIXATION, BONE, DEVICE PRODUCT CODE¿JDS, 510(K) K072095. 212.112S, LOT L035490, 3.5 MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 32 MM, COMMON NAME¿NAIL, FIXATION, BONE, DEVICE PRODUCT CODE¿JDS, 510(K) K072095. 212.111S, LOT 9869825, 3.5 MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 30 MM, COMMON NAME¿NAIL, FIXATION, BONE, DEVICE PRODUCT CODE¿JDS, 510(K) K072095. 212.105S, LOT L054538, 3.5 MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18 MM, COMMON NAME¿NAIL, FIXATION, BONE, DEVICE PRODUCT CODE¿JDS, 510(K) K072095. (EXPIRATION DATE), DEVICE HISTORY RECORD REVIEWS WERE PERFORMED FOR THE REPORTED LOT NUMBERS OF THE IMPLANTED SCREWS. MANUFACTURING LOCATION: (B)(4). PART 212.109S LOT L091290. MANUFACTURING DATE: 10. AUG. 2016. EXPIRY DATE: 01. JULY 2026. PART 212.112S LOT L035490. MANUFACTURING DATE: 23. JUNE 2016. EXPIRY DATE: 01. JUNE 2026. PART 212.111S LOT 9869825. MANUFACTURING DATE: 14. MAR. 2016. EXPIRY DATE: 01. MAR. 2026. PART 212.105S LOT L054538. MANUFACTURING DATE: 08. JULY 2016. EXPIRY DATE: 01. JUNE 2026. 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 IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION AND IS STILL IMPLANTED IN THE PATIENT. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (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

    SYNTHES EUROPE REPORTED AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO (2) UNKNOWN PROXIMAL 3.5 MM LOCKING SCREWS THROUGH AND UNKNOWN PLATE HAVE BROKEN POSTOPERATIVELY JUST UNDER THE LOCKING HEADS. THE SCREW HEADS REMAIN ATTACHED TO THE PLATE AND THE SCREW SHAFTS ATTACHED TO THE BONE. THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2016 FOR A DISTAL HUMERAL SHAFT FRACTURE. THE PATIENT RETURNED ON (B)(6) 2016 FOR A POST-OPERATION REVIEW WHERE EVERYTHING WAS SEEMINGLY OKAY. THE PATIENT THEN PRESENTED AT THE HOSPITAL ON (B)(6) 2017 ABLE TO MOVE HIS ARM BUT WITH UPPER ARM PAIN UPON SHOULDER ABDUCTION. AS A RESULT HE WAS SENT FOR X-RAY WHICH SHOWS THAT TWO (2) UNKNOWN 3.5, PROXIMAL LOCKING SCREWS ABOVE THE FRACTURE HAVE BOTH BROKEN BELOW THE HEADS OF THE SCREW. HIS FRACTURE HAS REMAINED REDUCED BY THE TWO INTER-FRAGMENTARY LAG SCREWS AND HAS CONTINUED TO HEAL. HIS RADIAL NERVE PALSY IS IMPROVING. THE FRACTURE HAS CONTINUED TO HEAL AND NO FURTHER REVISION SURGERY HAS BEEN REQUIRED. A DECISION WAS MADE TO MONITOR THE PATIENT RATHER THAN TO RE-OPERATE TO ALLOW THE BONE TO HEAL. THERE IS NO PLAN TO REMOVE THE BROKEN SCREWS AS THIS WOULD RISK FURTHER INJURY TO HIS RADIAL NERVE. CONCOMITANT REPORTED PART: 1X LOCKING COMPRESSION DISTAL HUMERAL PLATE (PART 02.104.028S LOT 8992297). THIS REPORT IS FOR TWO (2), UNKNOWN LOCKING SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108699 NAIL, FIXATION, BONE JDS SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention 02.104.028S, 3.5MM LCP DISTAL HUMERUS PL 8H/LT 194