BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY, SUGRICAL

    MDR report key: 7041667 · Received November 17, 2017

    Report

    Report Number
    2520274-2017-12664
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Report Date
    October 25, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN UNK CAB 1 SET/UNKNOWN LOT NUMBER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. CONCOMITANT DEVICE: UNK CAB 1 SET. UNKNOWN WHICH PASSERS CAUSED THE ISSUE: 1X 391.103 / LOT P050587 (CABLE PASSER, MEDIUM, CURVED), 1X 391.108 / LOT P076240 (CABLE PASSER, LARGE, 45° ANGLE), 1X 391.104 / P076239 (CABLE PASSER, LARGE, CURVED), 1X 391.105 / P063554 (CABLE PASSER, MEDIUM), 1X 391.106 / P076016 (CABLE PASSER, MEDIUM, 45° ANGLE), 1X 391.107 / P078759 (CABLE PASSER, LARGE). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED FOR THE FOLLOWING CONCOMITANT DEVICES: PART NUMBER: 391.103 SYNTHES LOT NUMBER: P050587 SUPPLIER LOT NUMBER: (B)(4) RELEASE TO WAREHOUSE DATE: 24-APR-2009 SUPPLIER: (B)(4) DHR REVIEW PART NUMBER: 391.108 SYNTHES LOT NUMBER: P076240 SUPPLIER LOT NUMBER: (B)(4) RELEASE TO WAREHOUSE DATE: 14-JUL-2010 SUPPLIER: (B)(4) DHR REVIEW PART NUMBER: 391.104 SYNTHES LOT NUMBER: P076239 SUPPLIER LOT NUMBER: (B)(4) RELEASE TO WAREHOUSE DATE: 28-JUL-2010 SUPPLIER: (B)(4) DHR REVIEW PART NUMBER: 391.105 SYNTHES LOT NUMBER: P063554 SUPPLIER LOT NUMBER: (B)(4) RELEASE TO WAREHOUSE DATE: 07-JAN-2010 SUPPLIER: (B)(4) DHR REVIEW PART NUMBER: 391.106 SYNTHES LOT NUMBER: P076016 SUPPLIER LOT NUMBER: (B)(4) RELEASE TO WAREHOUSE DATE: 08-JUN-2010 SUPPLIER: (B)(4) DHR REVIEW PART NUMBER: 391.107 SYNTHES LOT NUMBER: P078759 SUPPLIER LOT NUMBER: (B)(4) RELEASE TO WAREHOUSE DATE: 04-AUG-2010 SUPPLIER: (B)(4) NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCTS, AND ANY SUBCOMPONENTS, WHICH 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.

    Additional Manufacturer Narrative · 1

    SIX (6) ADDITIONAL PARTS ADDED TO COMPLAINT. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE INVESTIGATION SUMMARY INDICATES THAT THE:1X 391.103/LOT P050587 (CABLE PASSER, MEDIUM, CURVED). THE VISUAL INSPECTION HAS SHOWN THAT SIGNS OF BROWN RESIDUES COULD BE FOUND INSIDE THE POUCHES. DURING THE INVESTIGATION, THE DEVICE HISTORY FOR THE RETURNED PARTS WAS REVIEWED. NO NCRS WERE GENERATED DURING PRODUCTION. AS THE COMPLAINT POINTS TOWARDS THE BROWN RESIDUES, NO, MEASUREMENTS, NO HARDENING AND NO FURTHER TESTS WERE PROVIDED. CONCLUSION: NO MANUFACTURING RELATED DEVIATION COULD BE FOUND. AS A POSSIBLE ROOT CAUSE, IT IS LIKELY THAT THE PROVIDED WASHING AND DECONTAMINATION CYCLES MIGHT HAVE NOT BEEN REPEATED OFTEN ENOUGH TO OBTAIN CLEAN INSTRUMENTS. VISUAL EXAMINATION PROVIDED BY CHU. DHR-REVIEW; NO FINDINGS. 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

    DATE CORRECTION. DATE RECEIVED BY MANUFACTURER: REMOVE 20OCT2017 AND REPLACE WITH 20NOV2017. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICES (UNKNOWN PASSER). THE SUBJECT DEVICES WERE RETURNED WITH THE COMPLAINT CONDITION STATING VISUAL INSPECTION SHOWED SIGNS OF BLOOD OR OTHER BODY FLUID COULD BE FOUND ON THE DEVICES. IT IS UNKNOWN WHICH PASSER HAD CAUSED THE ISSUE. NO MEASUREMENTS, NO HARDENING OR FURTHER TESTS WERE PROVIDED. COMPLAINED ISSUE COULD BE CONFIRMED. FOLLOWING ARTICLES WERE RETURNED AND INVESTIGATED: 1X 391.103 / LOT P050587 (CABLE PASSER, MEDIUM, CURVED); 1X 391.108 / LOT P076240 (CABLE PASSER, LARGE, 45° ANGLE); 1X 391.104 / P076239 (CABLE PASSER, LARGE, CURVED); 1X 391.105 / P063554 (CABLE PASSER, MEDIUM); 1X 391.106 / P076016 (CABLE PASSER, MEDIUM, 45° ANGLE); 1X 391.107 / P078759 (CABLE PASSER, LARGE). DHR REVIEW: PART NUMBER: 391.103, SYNTHES LOT NUMBER: P050587, RELEASE TO WAREHOUSE DATE: 24-APR-2009. PART NUMBER: 391.108, SYNTHES LOT NUMBER: P076240, RELEASE TO WAREHOUSE DATE: 14-JUL-2010. PART NUMBER: 391.104, SYNTHES LOT NUMBER: P076239, RELEASE TO WAREHOUSE DATE: 28-JUL-2010. PART NUMBER: 391.105, SYNTHES LOT NUMBER: P063554, RELEASE TO WAREHOUSE DATE: 07-JAN-2010. PART NUMBER: 391.106, SYNTHES LOT NUMBER: P076016, RELEASE TO WAREHOUSE DATE: 08-JUN-2010. PART NUMBER: 391.107, SYNTHES LOT NUMBER: P078759, RELEASE TO WAREHOUSE DATE: 04-AUG-2010. NO NCRS WERE GENERATED DURING PRODUCTION IN ANY OF THE DEVICES INVESTIGATED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THESE PRODUCTS, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO MANUFACTURING RELATED DEVIATION COULD BE FOUND. AS POSSIBLE ROOT CAUSE THE WASHING AND DECONTAMINATION CYCLES MAY NOT HAVE BEEN SUFFICENT TO CLEAN THE DEVICES. 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. 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

    ADDITIONAL DHR INFORMATION FOR THE FOLLOWING PART NUMBERS: PART NUMBER: 391.103 PART NUMBER: 391.108 PART NUMBER: 391.104 PART NUMBER: 391.105 PART NUMBER: 391.106 PART NUMBER: 391.107 NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCTS, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: WHEN THE REPORTED CAB-1 (THE NAME OF THE SURGICAL TOOL SET ASSORTED IN (B)(6)) WAS ABOUT BEING WASHED POSTOPERATIVELY, IT WAS FOUND THAT SOME BROWN-COLORED LIQUID WAS LEAKING FROM THE PASSER HANDLES. IT WAS UNCERTAIN WHICH PASSER(S) HAD CAUSED THE ISSUE. THE DEVICES IN QUESTION WERE NOT USED FOR THE PATIENT. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT DEVICE: 1X 391.103 / LOT P050587 (CABLE PASSER, MEDIUM, CURVED), 1X 391.108 / LOT P076240 (CABLE PASSER, LARGE, 45° ANGLE), 1X 391.104 / P076239 (CABLE PASSER, LARGE, CURVED), 1X 391.105 / P063554 (CABLE PASSER, MEDIUM), 1X 391.106 / P076016 (CABLE PASSER, MEDIUM, 45° ANGLE), 1X 391.107 / P078759 (CABLE PASSER, LARGE). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE 16JAN. 2018: COMPLAINT RE-OPENED FOR 6 PARTS ADDED. THIS REPORT IS 1 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819677 TRAY, SUGRICAL LRP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1