BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE ¿3.2 F/PFNA BLADE

    MDR report key: 7209061 · Received January 22, 2018

    Report

    Report Number
    8030965-2018-50522
    Event Type
    Malfunction
    Date Received
    January 22, 2018
    Date of Event
    December 8, 2017
    Report Date
    December 12, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    07611819291355
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE WAS LISTED BETWEEN AGES 40-50, PATIENT IDENTIFIER, DATE OF BIRTH, AGE AND WEIGHT NOT AVAILABLE FOR REPORTING. DEVICE WAS RE-ASSESSED BASED ON INITIAL INVESTIGATION REQUIREMENTS AND WAS DEEMED REPORTABLE ON JANUARY 19, 2018. LOT WAS IDENTIFIED AS EITHER LOT# L572079 OR L572078. IT WAS UNDETERMINED WHICH LOT WAS IMPACTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A DEFINITIVE LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    THERAPY DATE: (B)(6) 2017. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 356.830, SYNTHES LOT NUMBER: L572079, RELEASE TO WAREHOUSE DATE: 16 OCT 2017, MANUFACTURING SITE: (B)(4), NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 356.830, SYNTHES LOT NUMBER: L572078, RELEASE TO WAREHOUSE DATE: 13 OCT 2017, MANUFACTURING SITE: (B)(4), NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. TWO OF THE THREE RETURNED GUIDE WIRES PRESENT DAMAGES AS FOLLOWS: GUIDE WIRE 356.830, LOT: UNKNOWN (POSSIBLE LOT NUMBERS IDENTIFIED AS L572079 OR L572078): THREADED TIP IS CUT OFF AND MISSING. GUIDE WIRE PART # UNKNOWN: TWO CENTIMETER BEHIND THE TIP A DEEP CUT IS VISIBLE. BOTH GUIDE WIRES SHOW FRETTING MARKS OVER THE WHOLE LENGTH, WHICH MAKES IT IMPOSSIBLE TO IDENTIFY THE EXACT PART AND LOT NUMBERS. THE REVIEW OF THE DEVICE HISTORY RECORDS (FOR LOT # L572079 AND L572078) REVEALED THAT BOTH LOT NUMBERS WERE MANUFACTURED IN OCTOBER 2017 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. DIAMETER OF THE GUIDE WIRES, MEASURED AT AN UNDAMAGED AREA, MEASURES 3.19MM, WHICH COMPLY WITH THE SPECIFICATIONS. FURTHER DIMENSIONAL INSPECTION COULD NOT BE PERFORMED DUE TO THE DAMAGE INCURRED. THE GUIDE WIRES ARE MADE FROM STAINLESS STEEL (1.4441). A FUNCTION CHECK WITH THE RETURNED INSTRUMENTS WAS PERFORMED AND DIDN'T SHOW ANY ABNORMALITIES. THE ASSEMBLY OF THE INSTRUMENTS DID WORK AS INTENDED. THE GUIDE WIRE IS GUIDED THROUGH DRILL SLEEVE (03.037.018); THIS ENSURES THE CORRECT ALIGNMENT OF THE GUIDE WIRE. THE TROCAR HAS NO INFLUENCE ONTO THE ALIGNMENT. NEITHER A PRODUCT NOR A FUNCTION FAULT COULD BE DETECTED. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED, THIS COMPLAINT CONDITION IS LIKELY A RESULT OF METHOD OF USE. LATERAL STRAIN DURING USE MIGHT HAVE CAUSED A SLIGHT BENDING OF THE GUIDE WIRE AND FOSTER THE REAMER TO CUT INTO THE WIRE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. CORRECTED DATA: PHYSICAL MANUFACTURER: 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROXIMAL FEMUR NAILING ON (B)(6) 2017, A K WIRE SHEARED OFF INTRAOPERATIVELY. DURING INSERTION OF THE DRILL OVER THE K-WIRE, THE K-WIRE WAS CUT THROUGH BY THE DRILL. BACK UP INSTRUMENTATION WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. A FIFTEEN (15) MINUTE SURGICAL DELAY WAS REPORTED. CONCOMITANT DEVICES: DRILL BIT (PART# 03.037.022, LOT# F-16763, QTY 1). INSERTION HANDLE (PART# 03.037.011, LOT# 8921813, QTY 1). CONNECTING SCREW (PART# 03.037.010, LOT# 9219128 QTY 1). AIMING ARM (PART# 03.037.114, LOT# L178546 QTY 1). TROCAR (PART# 03.037.019, LOT# 9079765, QTY 1). AIMING ARM LOCKING DEVICE (PART# 03.037.015, LOT# L122025, QTY 1). COMPRESSION NUT (PART# 03.037.016, LOT# 8947771, QTY 1). GUIDE WIRE SLEEVE (PART# 03.037.018, LOT# 8901948, QTY 1). SCREW GUIDE SLEEVE (PART# 03.037.017, LOT# 9066435, QTY 1). GUIDE WIRE (PART# 356.830, LOT# L572079 OR L572078, QTY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    FURTHER IT WAS REPORTED THAT THE TIP OF THE GUIDE WIRE WAS NOT LEFT BEHIND IN THE PATIENT, THE TIP WAS REMOVED FROM THE PATIENT AND WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53274 GUIDEWIRE ¿3.2 F/PFNA BLADE GUIDE FZX OBERDORF : SYNTHES PRODUKTIONS GMBH 07611819291355

    Patients

    Seq Age Sex Outcome Treatment
    1