BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4942511 · Received July 27, 2015

    Report

    Report Number
    3000270450-2015-10148
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 17, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PK102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: 04.210.118 / 7710395, MANUFACTURING DATE: 09/18/14, 7710395, 7710373, 7711511, 7915420 & 7373816: NO NCRS WERE GENERATED DURING PRODUCTION. 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. DHR REVIEW SHOWED NO ISSUES. INVESTIGATION WAS NOT POSSIBLE DUE THE MISSING MATERIAL. 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 MANUFACTURING DATE (SEPTEMBER 18, 2014) REPORTED IN THE FIRST FOLLOW-UP MEDWATCH WAS SUBMITTED IN ERROR. THAT DATE CORRESPONDS WITH ONE OF THE ASSOCIATED, NON-STERILE, PART/LOT COMBINATIONS, WHICH WERE ALSO REVIEWED FOR NON-CONFORMANCES.SINCE THE COMPLAINANT DEVICE ITSELF WAS REPORTEDLY A STERILE PART, THE MANUFACTURING DATES BELOW ARE APPLICABLE:LOT 9201295 - OCTOBER 16, 2014;LOT 9269970 - DECEMBER 2, 2014;LOT 9296095 - DECEMBER 23, 2014;LOT 9487963 - MAY 19, 2015. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE ASSOCIATED NON-STERILE PARTS WAS CONDUCTED WITH RESULTS AS FOLLOWS:ALL PART/LOT COMBINATIONS WERE MANUFACTURED AT (B)(4).PART 04.210.118 / LOT 7710395 - MANUFACTURING DATE: SEPTEMBER 18, 2014;PART 04.210.118 / LOT 7710373 - MANUFACTURING DATE: NOVEMBER 16, 2014;PART 04.210.120 / LOT 7711511 - MANUFACTURING DATE: NOVEMBER 20, 2014;PART 04.210.122 / LOT 7915420 - MANUFACTURING DATE: APRIL 29, 2015;PART 04.210.124 / LOT 7373816 - MANUFACTURING DATE: MAY 16, 2013.NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION FOR ANY OF THE ABOVE MENTIONED LOTS. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION.DEVICE 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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR AN UNKNOWN SCREW WITH POSSIBLE PART/LOT COMBINATIONS LISTED BELOW: 04.210.118S / LOT 9201295 - 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE / HRS ¿ PLATE, FIXATION, BONE / K102694 / (B)(4) / EXPIRY: OCTOBER 1, 2024. 04.210.118S / LOT 9269970 - 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE / HRS ¿ PLATE, FIXATION, BONE / K102694 / (B)(4) / EXPIRY: NOVEMBER 1, 2024. 04.210.120S / LOT 9296095 - 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE / HRS ¿ PLATE, FIXATION, BONE / K102694 / (B)(4) / EXPIRY: DECEMBER 1, 2024. 04.210.122S / LOT 9487963 - 2.4MM TI VA LOCKING SCREW STARDRIVE 22MM-STERILE / HRS ¿ PLATE, FIXATION, BONE / K102694 / (B)(4) / EXPIRY: MAY 1, 2025. 04.210.124S / LOT 8488115 - 2.4MM TI VA LOCKING SCREW STARDRIVE 22MM-STERILE / HRS ¿ PLATE, FIXATION, BONE / K102694 / (B)(4). IT IS UNKNOWN IF THE REPORTED SCREW WAS IMPLANTED OR REMOVED DURING THE PROCEDURE. POSSIBLE MANUFACTURING DATES LISTED BELOW: LOT 9201295 - OCTOBER 16, 2014. LOT 9269970 - DECEMBER 2, 2014. LOT 9296095 - DECEMBER 23, 2014. LOT 9487963 - MAY 19, 2015. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: THE RESULTS BELOW ARE FOR EACH OF THE POSSIBLE PART/LOT COMBINATIONS THAT WERE PROVIDED BY THE REPORTER. PART 04.210.118S / 9201295. MANUFACTURING DATE: OCTOBER 16, 2014 - EXPIRY DATE: OCTOBER 1, 2024. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON-STERILE PART WERE REVIEWED WITH THE FOLLOWING RESULT: NO NON-CONFORMANCE REPORTS (NCR) WERE GENERATED DURING PRODUCTION. 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. PART 04.210.118S / 9269970. MANUFACTURING DATE: DECEMBER 2, 2014 - EXPIRY DATE: NOVEMBER 1, 2024. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON-STERILE WERE REVIEWED WITH THE FOLLOWING RESULT: NO NCRS WERE GENERATED DURING PRODUCTION. 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. PART 04.210.120S / 9296095. MANUFACTURING DATE: DECEMBER 23, 2014 - EXPIRY DATE: DECEMBER 1, 2024. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON-STERILE WERE REVIEWED WITH THE FOLLOWING RESULT: NO NCRS WERE GENERATED DURING PRODUCTION. 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. PART 04.210.122S / 9487963. MANUFACTURING DATE: MAY 19, 2015 - EXPIRY DATE: MAY 1, 2025. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON-STERILE WERE REVIEWED WITH THE FOLLOWING RESULT: NO NCRS WERE GENERATED DURING PRODUCTION. 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. DEVICE 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2015 TO REPAIR A DISTAL RADIUS FRACTURE ON THE LEFT. DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO LOCK ONE OF THE REPORTED SCREWS. THE SCREW WAS REMOVED AND A METAL PIECE WAS FOUND AT THE OPERATING REGION ¿ THE SURGEON DID NOT KNOW IF THE PIECE CAME FROM THE SCREW OR THE PLATE. THE FRAGMENT WAS CLEARED OUT AND ANOTHER ATTEMPT WAS MADE TO INSERT/LOCK THE SAME SCREW. THE SCREW STILL COULD NOT BE LOCKED, BUT THE SURGEON PROCEEDED WITH THE SURGERY. IT IS UNKNOWN IF THE SCREW WAS REPLACED OR IF IT WAS LEFT IN THE PATIENT UNLOCKED. THE PROCEDURE WAS PROLONGED BY THREE (3) MINUTES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486297 PLATE, FIXATION, BONE HRS SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1