BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6MM/9MM CANNULATED STEPPED DRILL BIT

    MDR report key: 10928323 · Received December 1, 2020

    Report

    Report Number
    8030965-2020-09282
    Event Type
    Injury
    Date Received
    December 1, 2020
    Report Date
    November 4, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819642485
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE INSPECTION HAS SHOWN THAT 3 OF THE 4 TIPS AT THE FOREFRONT ARE BROKEN OFF, NO FRAGMENTS WERE RETURNED FOR EVALUATION. IN GENERAL IS THE DEVICE IN A USED CONDITION WITH SLIGHTLY WORN CUTTING EDGES AND DIFFERENT STRESS MARKS AT THE SHAFT AND THE COUPLING ADAPTER. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER PER RELEVANT DRAWING : OUTER DIAMETER SPECIFICATION = PASS , INNER DIAMETER SPECIFICATION = PASS, CUT IN DIAMETER AT FRACTURE FACE SPECIFICATION = PASS . DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWING WAS REVIEWED TO VERIFY THE RELEVANT DIMENSIONS, THE MATERIAL AND THE HARDNESS SPECIFICATION. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT WITH 440A (1.4109) STAINLESS STEEL THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS WITH IN THE SPECIFICATION AS REQUIRED PER RELEVANT DRAWING . THE TFNA PROXIMAL FEMORAL NAILING SYSTEM SURGICAL TECHNIQUE (DSEM/TRM/0514/0052 103332-181129 DSEM 12/18) WAS REVIEWED, RELATED TO THE GUIDE WIRE INSERTION FOLLOWING STATEMENT FORM PAGE 32 CAN BE POINTED OUT: DO NOT REUSE GUIDE WIRES, AS THEY MAY BEND DURING INITIAL USE. IF THE GUIDE IS DEFORMED DURING INSERTION USE A NEW GUIDE AND DISCARD THE DEFORMED GUIDE WIRE INVESTIGATION CONCLUSION: THE COMPLAINT IS RATED AS CONFIRMED AS 3 OF THE 4 TIPS AT THE FOREFRONT OF THE REAMER ARE BROKEN OFF. THE BREAKAGE AND THE EMBEDDED FRAGMENTS CAN ALSO BE CONFIRMED ON THE RECEIVED X-RAYS. DURING THE PERFORMED EVALUATION NO MANUFACTURING RELATED ISSUE COULD BE DETECTED. BASED ON THE PROVIDED INFORMATION IS CAN ONLY BE ASSUMED THAT AN EXCESSIVE CONTACT BETWEEN THE REAMER AND THE BEND GUIDE WIRE DID LEAD TO THE BREAKAGE OF THE TIPS AT THE FOREFRONT OF THE REAMER. THE MENTIONED DEFORMATION OF THE GUIDE WIRE WOULD ALSO EXPLAIN WHY THE WIRE WAS STUCK IN THE REAMER AFTER THE REMOVAL. 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. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PRODUCT CODE: 03.037.022 LOT NUMBER: F-22662, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 05. OCT. 2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO FOR THE COMPLAINT CONDITION RELEVANT NON-CONFORMANCES WERE IDENTIFIED. REMARK: NR IS MENTIONED IN THE DOCUMENTS, THIS IS A PLANNED NC FOR THE SUPPLIER SPHINX IN RELATION TO A TRANSFER PROJECT WITHOUT INFLUENCE ON THE PRODUCT ITSELF. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A TFNA CASE, USING THE DRILL, DARK SHADOWS WERE FOUND AROUND THE WIRE. AFTER REMOVING THE DRILL FROM THE PATIENT, PARTS OF THE TIP OF THE DRILL WAS BROKEN OFF AND THE WIRE WAS STUCK IN THE DRILL. ONCE THE WIRE WAS REMOVED, IT WAS FOUND TO BE BENT. THERE WAS METAL LEFT IN THE FEMORAL HEAD BUT THE SURGERY CONTINUE WITHOUT DELAY. THIS REPORT IS FOR ONE (1) 6MM/9MM CANNULATED STEPPED DRILL BIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391900 6MM/9MM CANNULATED STEPPED DRILL BIT BIT, DRILL HTW SYNTHES GMBH F-22662 07611819642485

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention