BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/100MM

    MDR report key: 9513616 · Received December 23, 2019

    Report

    Report Number
    8030965-2019-71404
    Event Type
    Injury
    Date Received
    December 23, 2019
    Date of Event
    December 9, 2019
    Report Date
    December 9, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    PMA / PMN Number
    K964259
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. D2: ADDITIONAL DEVICE PRODUCT CODE: JDO. D4: POTENTIAL LOT NUMBERS ARE H083104; H083105; H083106. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE RECEIVED DHS/DCS SCREW IS STRONGLY DAMAGED, THE TOP OF THE SCREW WITH THE OCTAGONAL RECESS IS TOTALLY DEFORMED. THERE ARE VERY STRONG STRESS MARKS AROUND THE DEFORMATION AT THE OUTSIDE AT THE SHAFT AND AS WELL AT THE INSIDE IN THE OCTAGON. A FRAGMENT OF A BROKEN CONNECTING SCREW IS STUCK IN THE OCTAGON RECESS. THE SHAFT HAS CLEARLY VISIBLE WEAR MARKS FROM LOAD BEARING DURING THE TIME IN SITU, THE LOT NUMBER IS JUST PARTIALLY READABLE DUE TO THESE WEAR MARKS. ONLY THE FIRST 4 DIGITS WITH H083 ARE READABLE, BASED ON THE ERP SYSTEM (SAP P01) IS WAS POSSIBLE TO BREAK THIS DOWN TO THE POTENTIAL LOTS H083106, H083104 OR H083105. FUNCTIONAL TESTING: NO FUNCTIONAL TEST WITH AN EXTRACTION INSTRUMENT CAN BE PERFORMED, DUE TO THE STRONGLY DEFORMED TOP IS THE DISTANCE BETWEEN THE FLAT SURFACES OUT OF SPECIFICATION AND IT IS THEREFORE IMPOSSIBLE TO ATTACH AN INSTRUMENT ONTO THE DHS/DCS SCREW. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER PER RELEVANT DRAWING: OUTER SHAFT DIAMETER INTACT PLACE AND DISTANCE FLAT SURFACES INTACT PLACE WERE CHECKED AND THEY ARE WITHIN SPECIFICATIONS. OUTER SHAFT DIAMETER DAMAGED TOP OF THE SHAFT AND DISTANCE FLAT SURFACES DAMAGED TOP OF THE SHAFT MEASURED AND FOUND TO BE DEFORMED. THE OCTAGONAL RECESS IS NOT MEASURABLE DUE TO THE STRONG DEFORMATION. DRAWING/SPECIFICATION REVIEW: RELEVANT DRAWING OF THE DHS/DCS SCREW 280.301 WAS REVIEWED TO VERIFY THE OUTER DIMENSIONS OF THE SCREW. RELEVANT DRAWING WAS REVIEWED FOR THE INNER DIMENSIONS OF THE DHS/DCS WRENCH 338.060. DURING THE REVIEW NO DESIGN RELATED ISSUE COULD BE DETECTED, THE REVIEW HAS SHOWN THAT THERE IS ENOUGH CLEARANCE BETWEEN THE DHS/DCS SCREW AND THE DHS WRENCH WHEN THE DEVICES ARE INTACT. THE DHS/DCS SYSTEM SURGICAL TECHNIQUE (036.000.255 DSEM/TRM/1114/0221(5) 02/17) WAS REVIEWED. BASED ON THAT IS THE DHS/DCS WRENCH PART 338.060 IN COMBINATION WITH THE CONNECTING SCREW LONG PART 338.220 USED FOR THE REMOVAL OF A DHS/DCS SCREW. ALSO FOLLOWING WARNING IS MENTIONED: NEVER USE THE INSERTION INSTRUMENTS FOR IMPLANT REMOVAL. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED FOR THE RECEIVED DHS/DCS SCREW BECAUSE IN THE CURRENT CONDITION NO EXTRACTION TOOL CAN BE ATTACHED ONTO THE SCREW, NEITHER TO THE OUTSIDE WITH THE WRENCH AS DESIGNED NOR TO THE INSIDE WITH THE OCTAGON. DURING THE EVALUATION NO MANUFACTURING RELATED ISSUE COULD BE DETECTED, ALL VISIBLE DAMAGES WERE CLEARLY CAUSED POST-MANUFACTURING. BASED ON THE PROVIDED INFORMATION THE EXACT CAUSE OF THIS OCCURRENCE CANNOT BE DEFINED, ESPECIALLY AS THE COMPLAINED SCREWDRIVER WITH THE INCORRECT SIZE WAS NOT RETURNED AND AS THE PART NUMBER OF THIS SCREWDRIVER IS UNKNOWN. AFTERWARDS IT CANNOT BE DEFINED WHEN OR HOW THE STRONG DEFORMATIONS ON TOP OF THE SCREW OCCURRED, IF THIS WAS SOLELY DURING THE REMOVAL OR IF THERE WAS ALREADY SOME DAMAGE PRESENT AFTER INSERTION. THE ALSO RECEIVED PLATE 02.224.224 CANNOT BE ATTACHED ANYMORE DUE TO THE DEFORMED FLAT SURFACES AT THE SCREW TOP, THIS INDICATES THAT THE MAIN DEFORMATION OCCURRED AFTER THE PLATE WAS REMOVED. IN THIS RELATION IT CAN BE POINTED OUT THAT THE PLATE HAS A SIMILAR CLEARANCE LIKE THE DHS/DCS WRENCH PART 338.060, WHICH IS ATTACHED TO THE OUTSIDE OF THE DHS SCREW FOR THE EXTRACTION AFTER THE PLATE IS REMOVED. THIS MEANS IF A REMOVAL OF THE PLATE IS POSSIBLE ATTACHING THE WRENCH FOR SCREW EXTRACTION SHOULD ALSO BE POSSIBLE. HOWEVER, BASED ON THE PROVIDED INFORMATION IT IS NOT KNOWN IF THE WRENCH DHS/DCS WRENCH PART 338.060 WAS USED AND/OR IF THERE WAS AN ISSUE WITH THIS DEVICE. BASED ON THE DESCRIPTION WAS THE BROKEN CONNECTING SCREW THE PART 03.224.008. THIS SCREW IS USED TOGETHER WITH THE EXTRACTION INSTRUMENT FOR DHS BLADE PART 03.224.005 WITH THE OCTAGON TIP. THE STRONG STRESS MARKS ON TOP OF THE INSIDE OF THE OCTAGON RECESS ALSO AN INDICATION THAT AN INSTRUMENT WITH OCTAGON RECESS WAS USED. BASED ON THE SURGICAL TECHNIQUE ARE THESE INSTRUMENTS ARE ACTUALLY USED FOR THE REMOVAL OF A DHS BLADE AND NOT FOR A DHS/DCS SCREW. 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. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 280.301, LOT NUMBER: H083104; H083105; H083106, PART MANUFACTURING DATE: 18 APRIL 2016; 18 APRIL 2016; 20 APRIL 2016, MANUFACTURING SITE: ELMIRA, PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: N/A. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORDS SHOW LOTS H083104, H083105, AND H083106 OF DHS/DCS ONE-STEP LAG SCREWS WERE PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THESE LOTS MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT 7888248 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THESE LOTS MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 · 0

    CONCOMITANT DEVICE REPORTED: UNKNOWN DHS BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); CORTEX SCREW (PART# 214.038, LOT# L109010, QUANTITY 1); CORTEX SCREW (PART# 214.040, LOT# 9894161, QUANTITY 1); CORTEX SCREW (PART# 214.040, LOT# 9700520, QUANTITY 1); CORTEX SCREW (PART# 214.042, LOT# 9903675, QTY 1); LCP DHS PLATE (PART# 02.224.224S, LOT# L023173 , QUANTITY# 1); CONNECSCR F/EXTRACTION DHS BLADE (PART # 03.224.008, LOT # UNKNOWN, QTY 1); SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/100MM.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 DURING HARDWARE REMOVAL PROCEDURE FOR RIGHT PROXIMAL FEMUR ON (B)(6) 2019, THE TIP OF THE COUPLING SCREW FOR EXTRACTION DHS BLADE HAS BROKEN OFF IN THE IMPLANT. SURGEON ATTEMPTED TO REMOVE THE DEVICE, BUT WAS NOT ABLE TO ADEQUATELY REMOVE THE SCREW IN THE DHS SYSTEM IN THE FEMORAL NECK COMPONENT. HE SAID THE SCREWDRIVER WAS OF THE INCORRECT SIZE AND THIS HAD HAPPENED BEFORE. THE SCREW WOULD NOT FIT WITH ANY OF THE DHS INSERTION TOOLS OR REMOVAL TOOLS. ALL THE DEVICES WERE EXPLANTED AS PLANNED AND PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN DHS BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN DHS SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN DHS PLATE (PART# 02.224.224S, LOT# L023173 , QUANTITY# 1). THIS REPORT IS FOR ONE (1) UNKNOWN SCREW-TRAUMA. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305466 DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/100MM APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention LCP DHS-PL 135° 4HO L92 STANDBARREL SST| UNK - NAIL HEAD ELEMENTS: DHS/DCS BLADE| UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW