BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIDING MECHANISM

    MDR report key: 5525108 · Received March 24, 2016

    Report

    Report Number
    3000270450-2016-10075
    Event Type
    Injury
    Date Received
    March 24, 2016
    Date of Event
    March 10, 2016
    Report Date
    March 10, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE HANDLE BROKE OFF WHILE RATCHETING. THE REPAIR TECHNICIAN REPORTED THE HANDLE WAS BROKEN WITH BOTH SCREENS MISSING. HANDLE CRACKED/BROKEN IS THE REASON FOR REPAIR; THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN, SO THE ITEM WILL BE FORWARDED FOR FURTHER EVALUATION. PRODUCT INVESTIGATION SUMMARY: THE FOLLOWING COMPLAINT DEVICES WERE RECEIVED FOR INVESTIGATION: ONE SLIDING MECHANISM (PART 314.291 / LOT 13-0748); ONE PELVIC ARM 225MM (PART 398.753 / LOT 10-1089) THE RETURNED SLIDING MECHANISM WAS EXAMINED .AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE BLACK POLYAMIDE 6/6 HANDLE WAS FOUND TO BE BROKEN AT THE DISTAL ATTACHMENT SCREW. THE REMAINDER OF THE INSTRUMENT OPERATED SMOOTHLY AS INTENDED AND DID NOT BIND. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; HOWEVER, THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH EXCESSIVE LOADING AND/OR ROUGH HANDLING OVER 3+ YEARS IN THE FIELD. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. MANUFACTURE DATE: JUNE 3, 2013 / RELEASE TO WAREHOUSE DATE: JUNE 27, 2013. DEVICE 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4) IT WAS REPORTED THAT THE SLIDING MECHANISM HANDLE BROKE OFF DURING SURGERY, X-RAYS WERE DONE TO CONFIRM THAT NO FRAGMENTS WERE RETAINED BY THE PATIENT. PATIENT OUTCOME IS PENDING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A SERVICE HISTORY REVIEW WAS ATTEMPTED ON: S&R SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 314.291 WITH LOT NUMBER(S) 13-0748 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 27-JUN-2013. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), SUPPLIER: LEITNER AG, MANUFACTURING DATE: 03.JUN.2013, PART # 314.291 LOT # 13-0748. NO 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. 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

    CLARIFICATION: THE MENTIONED PELVIC ARM WAS ASSESSED FOR REPORTABILITY AND DETERMINED TO BE NON-REPORTABLE FOR THE COMPLAINED ISSUE OF ¿STICKING.¿ THEREFORE, THIS COMPLAINT INVOLVED ONE (1) REPORTABLE PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN INITIAL PELVIC ACETABULUM PROCEDURE ON (B)(6) 2016, THE SLIDING MECHANISM HANDLE BROKE OFF WHILE RATCHETING DOWN. A DIFFERENT STYLE CLAMP WAS USED. X-RAYS WERE TAKEN (NOT AVAILABLE). IT WAS CONFIRMED THAT NO FRAGMENTS FELL IN PATIENT. THEN THE LOCKING MECHANISM ON THE PELVIC ARM STUCK. THE SURGEON HAD TO POUND WITH A HAMMER FOR IT TO RELEASE. THERE WAS NO DELAY REPORTED AT THIS TIME AS THE PROCEDURE WAS ONGOING. PATIENT OUTCOME PENDING. THERE ARE 2 DEVICES IN THIS COMPLAINT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178549 SLIDING MECHANISM FORCEPS HTD SYNTHES SELZACH 13-0748

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention