BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION FORCEPS

    MDR report key: 5041880 · Received August 31, 2015

    Report

    Report Number
    9680938-2015-10080
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 19, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HWN
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART#03.211.400, LOT# T959508 ((B)(4)), PRODUCT: COMPRESSION FORCEPS , MANUFACTURING LOCATION: SYNTHES (B)(4), MANUFACTURING DATE: 05/03/2011, PART #: 03.211.400, LOT# : T959508- COMPRESSION FORCEPS , QUANTITY (B)(4). LOT WAS RELEASE TO THE WAREHOUSE ON 05/03/2011. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 NARRATIVE: PRODUCT INVESTIGATION SUMMARY: THE COMPLAINT CONDITION FOR THE COMPRESSION FORCEPS (PART 03.211.400 / LOT T959508) WAS LIKELY CAUSED BY OVER FOUR YEARS OF USE AND POSSIBLY THE APPLICATION OF EXCESSIVE FORCE DURING SURGERY; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE COMPRESSION FORCEPS ARE AN INSTRUMENT ROUTINELY USED IN THE 2.7MM VARIABLE ANGLE LOCKING CALCANEAL PLATING SYSTEM PER TECHNIQUE GUIDE. THE DEVICE WAS RETURNED AND REPORTED THAT THE TIP HAD BROKEN DURING SURGERY. THIS CONDITION IS CONFIRMED; THE TIP OF ONE OF THE ARMS HAS BROKEN OFF THE DEVICE APPROXIMATELY THREE MILLIMETERS FROM THE MOST DISTAL TIP. IT IS LIKELY THAT OVER FOUR YEARS OF USE AND POSSIBLY THE APPLICATION OF EXCESSIVE FORCE DURING SURGERY HAVE LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN MAY, 2011 AND IS OVER FOUR YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN OTHERWISE FAIRLY GOOD CONDITION WITH FEW SIGNS OF WEAR. THE ASSOCIATED DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. IT IS LIKELY THAT OVER FOUR YEARS OF USE AND POSSIBLY THE APPLICATION OF EXCESSIVE FORCE DURING SURGERY HAVE LED 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

    IT WAS REPORTED THAT A PATIENT WENT TO SURGERY FOR A SPLINT DEFORMED FOOT OSTEOTOMY ON (B)(6) 2015. DURING THE SURGERY A TIP BROKE OFF OF A COMPRESSION FORCEPS INSTRUMENT. THE TIP WAS EASILY RETRIEVED WITHOUT ADDITIONAL INTERVENTION AND THE SURGEON FINISHED THE PROCEDURE WITH AN INSTRUMENT FROM A BACK-UP SET. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL TIME DELAY AND NO SURGICAL/MEDICAL INTERVENTION. THE PATIENT STATUS/OUTCOME IS OKAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575106 COMPRESSION FORCEPS INSTRUMENT COMPRESSION HWN SYNTHES TUTTLINGEN T959508

    Patients

    Seq Age Sex Outcome Treatment
    1