BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    MDR report key: 6363210 · Received February 27, 2017

    Report

    Report Number
    3000270450-2017-10061
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    February 1, 2017
    Report Date
    February 1, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    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. ADDITIONAL NARRATIVE: LOT NUMBERS USED IN THE REPORTED SURGERY ARE AS FOLLOWS: L203474, L155845, AND L203471. IT IS NOT KNOWN WHICH SCREW LOT NUMBER COULD NOT BE INSERTED. INFORMATION FOR THESE PART/COMBINATIONS IS AS FOLLOWS: PART NUMBER 04.503.104.04S, LOT NUMBER L203474, OTHER NUMBER¿UDI: (B)(4). PART NUMBER 04.503.104.04S, LOT NUMBER L155845, OTHER NUMBER¿UDI: (B)(4). PART NUMBER 04.503.104.04S, LOT NUMBER L203471, OTHER NUMBER¿UDI: (B)(4). MANUFACTURING LOCATION FOR ALL THREE LOTS IS SYNTHES (B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. (B)(6). THE 510(K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDERGOING INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED LOTS L203474, L155845, AND L203471. MANUFACTURING LOCATION: SYNTHES (B)(4). THE RESULTS ARE AS FOLLOWS: PART NUMBER 04.503.104.04S, LOT NUMBER L203474, MANUFACTURING DATE: 21.NOV.2016, EXPIRY DATE: 01.NOV.2026; PART NUMBER 04.503.104.04S, LOT NUMBER L155845, MANUFACTURING DATE: 06.OCT.2016, EXPIRY DATE: 01.SEP.2026; AND PART NUMBER 04.503.104.04S, LOT NUMBER L203471, MANUFACTURING DATE: 21.NOV.2016, EXPIRY DATE: 01.NOV.2026. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT LOTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE LOTS. 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. ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (BRAND NAME MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C, PART NUMBER 04.503.104.04S, LOT NUMBER UNKNOWN). LOT NUMBERS USED THE REPORTED EVENT ARE AS FOLLOWS: L203474, L155845, AND L203471. IT IS NOT KNOWN WHICH SCREW LOT NUMBER COULD NOT BE INSERTED. THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURER AND VISUAL INVESTIGATION WAS CONDUCTED USING A MICROSCOPE. THE COMPLAINT CONDITION WAS CONFIRMED. THE MICROSCOPIC INVESTIGATION REVEALED THAT THE TIP SECTION RIGHT ON THE FRONT DOES SHOW A SMALL PIECE IS BROKEN OFF. RECESS AND SCREW SHAFT DO NOT SHOW DAMAGES. NO FURTHER MANUFACTURING RELATED INVESTIGATION WAS POSSIBLE AS THREE DIFFERENT LOT NUMBERS WERE REPORTED AND IT IS UNCLEAR WHICH OF THEM DOES MATCH TO THIS RETURNED SCREW. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO FINDINGS FOR ALL OF THE THREE LOT NUMBERS. BASED ON THIS DHR-REVIEW IT WAS CONCLUDED THAT THIS SCREW DID NOT LEAVE MANUFACTURING PLANT WITH A BROKEN TIP SECTION. NO MANUFACTURING RELATED FAULT WAS FOUND. AN EXACT ROOT CAUSE COULD NOT BE DETERMINED HOWEVER, THAT THE SCREW TIP MIGHT HAVE BEEN BROKEN WHILE SETTING ONTO THE BONE WITH TOO MUCH FORCE. 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 HISTORY RECORDS REVIEW WAS COMPLETED FOR NON-STERILE LOTS. MANUFACTURING LOCATION: MONUMENT. PART #: 04.503.104.20, LOT#: H133205 (NON-STERILE). MANUFACTURING DATE: 30-JUN-2016; PART #: 04.503.104.20, LOT#: H140168 (NON-STERILE). MANUFACTURING DATE: 06-JUL-2016; PART #: 04.503.104.20, LOT#: H132926 (NON-STERILE). MANUFACTURING DATE: 30-JUN-2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS 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 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

    SYNTHES EUROPE REPORTED AN EVENT (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNSPECIFIED CRANIAL PROCEDURE ON (B)(6) 2017, WHEN THE SURGEON ATTEMPTED TO LOCK THE PLATE TO THE PATIENT¿S SKULL WITH THE SCREW, ONE (1) OF THE (4) SCREWS COULD NOT BE INSERTED INTO THE BONE AND COULD NOT BE IMPLANTED. THE SURGEON COMMENTED THAT THE SCREW TIP MAY HAVE BROKEN BUT THERE WERE NO FRAGMENTS FOUND INSIDE THE SURGICAL FIELD OR LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ADDITIONAL MEDICAL INTERVENTION OR PATIENT HARM. IT IS UNKNOWN THE REPORTED EVENT RESULTED IN A SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145359 MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C SCREW, FIXATION, BONE HWC SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1