BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAMER Ø11 F/PFNA BLADE

    MDR report key: 7573436 · Received June 6, 2018

    Report

    Report Number
    8030965-2018-54143
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    May 18, 2018
    Report Date
    July 12, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTO
    UDI-DI
    07611819291102
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    DHR REVIEW WAS COMPLETED. PART: 356.821. LOT: U241555. MANUFACTURING SITE: (B)(4). SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 04. APR. 2016. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL, HARDNESS AND MATERIAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE RAW MATERIAL CERTIFICATE WITH SUPPLIER LOT 252694-001 DOES CONFIRM MATERIAL CONFORMITY FOR THE USED (B)(4) STAINLESS STEEL. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. INVESTIGATION SITE: (B)(4). SELECTED FLOW: 5. BROKEN VISUAL INSPECTION: THE COMPLETE 6MM DIAMETER PART OF THE REAMER IS BROKEN OFF, THE FRAGMENT WAS NOT SENT BACK FOR EVALUATION. THE CUTTING EDGES ABOVE THE FRACTURE FACE ARE BADLY DAMAGED AND COMPLETELY BLUNT. IN GENERAL IS THE DEVICE IS A VERY USED CONDITION. THERE ARE MANY STRESS MARKS ALL OVER THE SHAFT AND THE COUPLING PIECE ON TOP HAS STRONG WEAR MARKS. DIMENSIONAL INSPECTION: NOT REQUIRED PER SELECTED INVESTIGATION FLOW AS THE CAUSE OF THE BREAKAGE IS USE RELATED. DRAWING/SPECIFICATION REVIEW: NOT REQUIRED PER SELECTED INVESTIGATION FLOW AS THE CAUSE OF THE BREAKAGE IS USE RELATED. MATERIAL OR HARDNESS REVIEW: NOT REQUIRED PER SELECTED INVESTIGATION FLOW AS THE CAUSE OF THE BREAKAGE IS USE RELATED. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE REAMER IS BROKEN AS COMPLAINED. THE REVIEW OF THE MANUFACTURING DOCUMENTS DID SHOW NO COMPLAINT RELATED ISSUES. THIS LOT OF (B)(4) PIECES WAS MANUFACTURED IN APRIL 2016 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT COMBINATION. THESE FINDINGS SPEAK AGAINST A MANUFACTURING RELATED ISSUE. THE VISUAL INSPECTION HAS SHOWN THAT THE CUTTING EDGES OF THE REAMER ARE BADLY DAMAGED AND THAT THE REAMER IS COMPLETELY BLUNT DUE TO THESE DAMAGES. THIS INDICATES THAT A MECHANICAL OVERLOAD EITHER BY AN INAPPROPRIATE EXCESSIVE METALLIC CONTACT, E.G. WITH THE NAIL, OR THE USE OF A PREVIOUSLY DAMAGED AND BLUNT REAMER CAUSED THE BREAKAGE. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THE REAMER AND THE DRILL BIT BROKE. THE BROKEN BITS WERE LEFT INSIDE THE PATIENT AS IT WAS DEEMED TOO DANGEROUS TO RETRIEVE THEM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED PROCEDURE WAS DELAYED APPROXIMATELY 5 TO 10 MINUTES. X-RAYS WERE TAKEN TO ENSURE THE FRAGMENTS WOULD NOT CAUSE ANY FURTHER HARM TO THE PATIENT. PATIENT STATUS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416754 REAMER Ø11 F/PFNA BLADE REAMER HTO OBERDORF SYNTHES PRODUKTIONS GMBH U241555 07611819291102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention