BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM

    MDR report key: 7394410 · Received April 3, 2018

    Report

    Report Number
    8030965-2018-52744
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 6, 2018
    Report Date
    March 7, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    07611819464032
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.010.472, LOT# 9042338. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: OCT 31, 2014. 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. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE EVALUATION SHOWED THAT THE STATIONARY TIP OF THE INTER-LOCK SCREWDRIVER WAS STRONGLY DEFORMED. THE COMPLAINT IS CONFIRMED. DUE TO THE DAMAGE OF THE TIP, THE RELEVANT DIMENSION COULD NOT BE VERIFIED. THE REVIEW OF THE MANUFACTURING DOCUMENTS SHOWED THAT THE DEVICE WAS MADE ACCORDING TO THE SPECIFICATION. THE LOT WAS MANUFACTURED IN OCTOBER 2014 WITH A LOT SIZE OF (B)(4) PIECES. ALL DEVICES WERE SOLD AND NO OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER COMBINATION WAS FOUND. BASED ON THESE FINDINGS, IT WAS CONCLUDED THAT THE CAUSE OF FAILURE WAS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. OUR EVALUATION SHOWED THAT ONLY THE STATIONARY TIP WAS DEFORMED, THE TIP OF THE SLIDER WAS NOT DEFORMED. THIS IS A CLEAR INDICATION THAT THE SLIDER WAS NOT INSERTED INTO THE SCREW RECESS AS DESIGNED. THEREFORE, THE FORCE WAS NOT DISTRIBUTED ON BOTH TIPS AS REQUIRED AND THE STATIONARY TIP DID GET DEFORMED BY A MECHANICAL OVERLOAD. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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 USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORDS REVIEW WAS REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL EVENT DESCRIPTION. CORRECTED DATA: REPORTER¿S NAME, EMAIL ADDRESS. 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: RETAINING SCREWDRIVER FOUND TO BE UNUSABLE IN THEATRE YESTERDAY (B)(6). REPORTED TO BQ TODAY (B)(6). SURGEON WANTED TO USE THIS SCREWDRIVER TO INSERT A LOCKING BOLT IN THE NAIL, HOWEVER, THE SCRUB NURSE WAS UNABLE TO INSERT THE SCREWDRIVER INTO THE SCREW AS THE END IS DEFORMED. THE SURGEON HAD TO USE THE NON RETAINING EQUIVALENT SCREWDRIVER AND NO HARM CAME TO THE PATIENT. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT PARTS, LOCKING BOLT (PART# UNKNOWN / LOT# UNKNOWN / QUANTITY 1), NAIL (PART# UNKNOWN / LOT# UNKNOWN / QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    FURTHER IT WAS REPORTED THAT THERE WAS NO DELAY IN SURGERY AND THE OPERATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235801 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM SCREWDRIVER HXX OBERDORF SYNTHES PRODUKTIONS GMBH 9042338 07611819464032

    Patients

    Seq Age Sex Outcome Treatment
    1