BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    MDR report key: 5981103 · Received September 27, 2016

    Report

    Report Number
    3000270450-2016-10232
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 9, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    KWQ
    PMA / PMN Number
    K152239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INITIALLY REPORTED AS SEPTEMBER 01, 2016; SHOULD HAVE BEEN SEPTEMBER 09, 2016. THIS REPORT IS FOR AN UNKNOWN SCREWDRIVER/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. POTENTIAL PART/LOT NUMBERS WERE PROVIDED, BUT IT IS UNKNOWN WHICH IS THE COMPLAINED DEVICE: PART 314.467 (STARDRIVE SCREWDRIVER SHAFT T8 105MM), LOT 7945573 OR 7867509; PRODUCT CODE: KWQ, APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY; (B)(4); 510K: K152239. PART 314.453 (STARDRIVE SCREWDRIVER SHAFT T8 55MM), LOT 9777639; PRODUCT CODE: HXX, SCREWDRIVERS; (B)(4); 510K: EXEMPT. CORRECTED DEVICE HISTORY RECORD REVIEW: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PART 314.467, LOT 7945573: MANUFACTURING LOCATION: (B)(4). RELEASE TO WAREHOUSE DATE: JUNE 15, 2015. SUPPLIER: (B)(4). PART 314.467, LOT 7867509: MANUFACTURING LOCATION: (B)(4). RELEASE TO WAREHOUSE DATE: MAY 04, 2015. SUPPLIER: (B)(4). PART 314.453, LOT 9777639: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: FEBRUARY 02, 2016. 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE FOLLOWING DEVICES WERE RECEIVED FOR INVESTIGATION; PART 314.453 / #LOT 9777639 / SCREWDRIVER SHAFT STARDRIVE® 2.4, SHORT, PART 314.467 / #LOT 7867509 / SCREWDRIVER SHAFT, STARDRIVE® T8, PART 314.467 / #LOT 7945573 / SCREWDRIVER SHAFT, STARDRIVE® T8. THE DISTAL TIPS OF THE RETURNED SCREWDRIVER ARE WORN AND THE CORNERS ARE SLIGHTLY ROUNDED. ADDITIONALLY, BLACK ABRASIONS ARE VISIBLE. THE SHAFTS AND COUPLINGS ARE OTHERWISE IN GOOD CONDITION. BECAUSE OF THE SLIGHTLY WORN TIPS, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS ANYMORE. THE MANUFACTURING DOCUMENTS SHOW THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICES MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING AND DISTRIBUTING. FAILURE IN MATERIAL OR PRODUCTION COULD NOT BE DETECTED. A FUNCTIONAL TEST WITH TWO LOCKING SCREWS 2.7 MM WAS PERFORMED TO REPRODUCE THE COMPLAINED ISSUE. ALL THREE SCREW DRIVER SHAFTS T8 PASSED THE FUNCTIONAL TEST SUCCESSFULLY. THE REPORTED EVENT OF "COULD NOT CONNECT THE SCREW" COULD NOT BE DUPLICATED. NOT FULLY SEATING THE SCREWDRIVER TIP OR NOT EXACTLY FOLLOWING THE SURGICAL TECHNIQUE MAY BE POSSIBLE CAUSES FOR THIS OCCURRENCE. SINCE NO MANUFACTURING RELATED CONDITIONS WERE FOUND, THIS COMPLAINT AS UNCONFIRMED. 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 USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. UNKNOWN WHICH OF THE FOLLOWING SCREWDRIVER SHAFTS WERE AFFECTED: 314.467 / 7945573, 314.467 / 7867509 "SCRDRIVER SHAFT T8 SELF-HOLD¿ OR 314.453 / 9777639 ¿SCRDRIVER SHAFT 2.4 SHORT SELF-HOLD.¿ (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DATE RETURNED TO MANUFACTURER PMA# OTHER: (EXEMPT) HXX. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. DHR REVIEW FOR: ART: 314.467 LOT: 7945573 MANUFACTURING LOCATION: (B)(4) / US, MANUFACTURING DATE: 22TH JUNE 2015, ARTICLE WAS MANUFACTURED IN THE US. ART: 314.467 LOT: 7867509, MANUFACTURING LOCATION: (B)(4) / US, MANUFACTURING DATE: 11TH MAY 2015, ARTICLE WAS MANUFACTURED IN THE US. ART: 314.453 / 9777639, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 2ND FEBRUARY 2016. NEITHER DEVIATION NOR ANY NCRS WERE MARKED IN THIS DOCUMENT COMPLAINT CONDITION. 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: HANDLE FOR TORQUE LIMITING ATTACHMENT (PART 03.110.005, LOT UNKNOWN, QUANTITY 1); TORQUE LIMITING ATTACHMENT 1.2NM (PART 03.110.002, LOT UNKNOWN, QUANTITY 1).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGERY WAS PERFORMED ON (B)(6) 2016. THE SURGEON PICKED OUT THE PROXIMAL LOCKING SCREW 2.7MM. BY USING THE TORQUE LIMITATION, HE TRIED TO CONNECT THE SCREW AND A SCREW DRIVER SHAFT. IT IS NOT SPECIFIED WHICH OF THE REPORTED SCREW DRIVER SHAFTS WAS USED. THE RESULT IS THAT HE COULD NOT CONNECT THE SCREW AND THE SCREW DRIVER SHAFT. THEN HE CHANGED TO THE OTHER SCREW DRIVER SHAFT AND DID CONNECT. THE TIP OF THE SCREW DRIVER SEEMED CHIPPED, THERE WAS A 5 MINUTES SURGICAL DELAY. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT DEVICE: 1X UNK SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633671 STARDRIVE SCREWDRIVER SHAFT T8 105MM APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 1X UNK SCREW