BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/125 DEG TI CANN TFNA 420MM/LEFT - STERILE

    MDR report key: 10190897 · Received June 24, 2020

    Report

    Report Number
    8030965-2020-04403
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    June 11, 2020
    Report Date
    June 11, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819649873
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: OCTOBER 12, 2015, EXPIRATION DATE: NOVEMBER 30, 2025, PART NUMBER: 04.037.033S, 10MM/125 DEG TI CANN TFNA 420MM/LEFT ¿ STERILE, LOT NUMBER: 9909040 (STERILE), LOT QUANTITY: 6. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINAL, NS063028 REV B MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, TFNA ASSEMBLY INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG LPPF, LMD / LPF WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILIZATION AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PARTS REVIEWED: PART NUMBER: 04.037.912.2, LOCK PRONG 125 DEGREE, TFNA, BP55, LOT NUMBER: 9477770, LOT QUANTITY: 96, PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55, LOT NUMBER: 7840793, LOT QUANTITY: 983. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATION AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD RECEIVED FROM SMALLEY DATED APRIL 2, 2015 WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE, BP58, LOT NUMBER: 9881387, LOT QUANTITY: 80, WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMOAGRI16.00, BP80, LOT NUMBER: 7744195, LOT QUANTITY: 1,264 LBS. PRODUCT CERTIFICATION SUPPLIED BY DYNAMET DATED JUNE 27, 2014 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED JULY 15, 2014 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE TFNA NAIL IS DAMAGED AT THE INSIDE THREAD AS REPORTED ¿HE (SURGEON) THEN TRIED THE SMITH AND NEPHEW CONICAL EXTRACTOR 7168-7111 AND FINALLY ACHIEVED PURCHASE IN THE PROXIMAL END OF THE NAIL. HE REMOVED IT SUCCESSFULLY FROM THERE.¿. FURTHERMORE, THE OUTER DIAMETER IS DAMAGED FROM A CUTTING TOOL, MOST LIKELY FROM CONICAL EXTRACTOR. IN ADDITION, THERE IS ANOTHER SIGN AT THE NECK SECTION. OTHERWISE, THE IMPLANT IS IN A GOOD CONDITION WITH JUST A FEW SIGNS OF USE. AS WELL AS, THE REPORTED FUNCTION PROBLEM IS BETWEEN THE TFNA NAIL AND THE EXTRACTION INSTRUMENT BY EXPLANTATION AND AS THE EXTRACTION INSTRUMENT IS DEFORMED / DAMAGED, THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION, SINCE THOSE DEFORMATION/DAMAGE CERTAINLY HAS AN IMPACT ON THE FUNCTION. FUNCTIONAL TEST: THE RELEVANT FEATURES ARE DEFORMED IN A MANNER WHICH PREVENTS ACCURATE FUNCTIONAL TEST. DIMENSIONAL INSPECTION: THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DAMAGE. DOCUMENT/SPECIFICATION REVIEW: DRAWINGS AND REVISIONS ARE IN ACCORDANCE TO DHR OF PRODUCTION LOT: 9909040. ALL RELEVANT FEATURES ARE DEFINED ON THE USED DRAWING REVISIONS OF DHR OF PRODUCTION LOT: 9909040. SUMMARY: THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS ITEM WAS MANUFACTURED IN OCTOBER 2015 ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION WERE FOUND. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. THERE IS NO PARTICULARIZE INFORMATION WHAT'S HAPPENED TO THIS ARTICLE BY CUSTOMER, UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT WE HAVE TO ASSUME THAT DURING THE OPERATION AN APPLICATION ERROR (INCORRECT APPLICATION) MAY HAVE TAKEN PLACE. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY TO OPERATE ACCORDING TO THE TECHNIQUE GUIDE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND / OR PREVENTATIVE ACTION IS PROPOSED. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4).THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT SURGERY FOR REMOVAL OF LEFT HIP NAIL. THE SURGEON ATTEMPTED TO REMOVE THE IN SITU PROXIMAL FEMORAL NAILING SYSTEM (TFNA) USING THE RECOMMENDED EXTRACTION INSTRUMENTS (PER THE SURGICAL TECHNIQUE). HE FIRST REMOVED THE DISTAL SCREW AND LOOSENED THE SET SCREW WITHOUT ISSUE. HE THEN INSERTED THE T-HANDLE EXTRACTOR INTO THE LATERAL END OF THE LAG SCREW. HE INITIALLY LEFT THIS IN PLACE BEFORE ATTEMPTING TO CONNECT THE EXTRACTION INSTRUMENT TO THE PROXIMAL END OF THE NAIL. HE THEN TRIED USING THE DEDICATED TFNA EXTRACTION SCREW (OVER A 3.2MM GUIDE WIRE) TO ENGAGE THE PROXIMAL END OF THE NAIL. HOWEVER, HE DID NOT HAVE SUCCESS WITH THIS INSTRUMENT AND AFTER 5-10 MINUTES HE DECIDED TO TRY ALTERNATE OPTIONS. HE THEN TRIED USING THE SMITH AND NEPHEW CONICAL EXTRACTORS WITHOUT SUCCESS. THE SURGEON THEN EXTENDED HIS EXCISION. HE THEN REMOVED THE LAG SCREW AND PLACED A GUIDEWIRE IN ITS PLACE. IN RE-ADDRESSING THE TOP OF THE NAIL, HE AGAIN TRIED USING TFNA EXTRACTION SCREW BUT WAS UNSUCCESSFUL. HE THEN TRIED THE SMITH AND NEPHEW CONICAL EXTRACTOR AND ACHIEVED PURCHASE IN THE PROXIMAL END OF THE NAIL. HE REMOVED IT SUCCESSFULLY FROM THERE. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. CONCOMITANT DEVICE REPORTED: EXTRACTION INSTRUMENT FOR TFNA HELICAL BLADE AND SCREW (PART # 03.037.030, LOT # UNKNOWN, QUANTITY 1), UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN LAG SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN GUIDEWIRE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 10MM/125 DEG TI CANN TFNA 420MM/LEFT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655816 10MM/125 DEG TI CANN TFNA 420MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 9909040 07611819649873

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention EXTRACT-INSTR F/NAILS CANN| EXTRACT-INSTR F/TFNA HELIC BLADE+SCR| TFNA SCR PERF L110 TAN| UNK - GUIDEWIRE| UNK - SCREWS: LAG| UNK - SCREWS: TRAUMA