BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10.2MM CANNULATED DRILL BIT LENGTH 251MM

    MDR report key: 9715428 · Received February 16, 2020

    Report

    Report Number
    8030965-2020-01168
    Event Type
    Injury
    Date Received
    February 16, 2020
    Date of Event
    January 23, 2020
    Report Date
    January 23, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWE
    UDI-DI
    07611819657311
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. H3, H4, H6: THE ARTICLE 03.168.005 WITH LOT F-22784 IS A SEMI-FINISHED PART (52 PIECES) AND GOT SOLD AS ARTICLE 03.168.004 WITH LOT F-22746 (49 PIECES) AND WITH LOT F-23215 (3 PIECES). PART: 03.168.004, LOT: F-22746, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 14.JUL.2017. A MANUFACTURING RECORD EVALUATION (MRE) IS NOT REQUIRED, AS THE PART IS FULLY FUNCTIONAL, AND AS WE ARE NOT ABLE TO REPRODUCE OR CONFIRM THIS INCIDENT. PART: 03.168.004, LOT: F-23215, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 01.DEC.2017. A MANUFACTURING RECORD EVALUATION (MRE) IS NOT REQUIRED, AS THE PART IS FULLY FUNCTIONAL, AND AS WE ARE NOT ABLE TO REPRODUCE OR CONFIRM THIS INCIDENT. VISUAL INSPECTION: UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE CUTTING EDGES AT THE TIP ARE WORN FROM USE. OTHERWISE, THE PART IS IN A USED BUT GOOD CONDITION. FUNCTIONAL TEST: DURING INVESTIGATION A FUNCTIONAL TEST WAS PERFORMED. THE THREE PARTS TOGETHER (DRILL BIT, REAMER AND NUT) PASSED THE FUNCTIONAL TEST. SUMMARY: UNFORTUNATELY, WE ARE NOT ABLE TO REPRODUCE THIS INCIDENT OR TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT WE ASSUME THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY WORN, INCOMPLETE OR DAMAGED INSTRUMENTS TO REPLACE AND/OR TO OPERATE ACCORDING TO THE TECHNIQUE GUIDE. WE ARE NOT ABLE TO REPRODUCE OR CONFIRM THIS INCIDENT, AS THE PART IS FULLY FUNCTIONAL, THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL NECK FRACTURE (AO CLASSIFICATION 31B1) WITH FNS. THE SURGEON USED PROTECTION SLEEVE (03.023.002) IN REAMING. HOWEVER, THE DRILL BIT PENETRATED THE BONE HEAD BECAUSE THE NUT WAS DETACHED FROM THE REAMER. THE SURGEON CONTINUED THE SURGERY AND INSERTED THE BOLT, ANTI-ROTATION-SCREW AND THE PLATE WITH LOCKING SCREW. THE SURGERY WAS COMPLETED WITH NO DELAY. THE SURGEON COMMENTED THAT HE OVER-REAMED BECAUSE THE NUT OF THE REAMER HAD BEEN LOOSED AND DETACHED. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: PROTECTION SLEEVE (PART # 03.023.002, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) DRILL BIT Ø10.2 CANN L251. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178617 10.2MM CANNULATED DRILL BIT LENGTH 251MM INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE OBERDORF SYNTHES PRODUKTIONS GMBH F-22784 07611819657311

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROTECT SLEEVE 20/17 F/PFNA-II