BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETENT PIN SCRDRIVER QC -HEX 12/ XL25

    MDR report key: 12616164 · Received October 12, 2021

    Report

    Report Number
    2939274-2021-05995
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Report Date
    September 14, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982292537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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. D9 - DATE DEVICE RETURNED TO MANUFACTURER. H6 - CODES UPDATED TO IMDRF CODES. NOTE: THE COMPLAINT DEVICE WAS EVALUATED AND INVESTIGATED BY THE R&D FACILITY AND BY THE MANUFACTURER: JABIL HAGENDORF. PLEASE REFER TO THE ATTACHMENTS "PC-000981804 ASSESSMENT R&D SIGN" AND "F-S021 PI-16318984794411016_PC-000981804" FOR THE INVESTIGATION REPORTS. VISUAL INSPECTION: THE RETENT PIN SCRDRIVER QC -HEX 12/ XL25 (PART# 03.045.006, LOT# 75P8426 QTY# 1) WAS RETURNED AND RECEIVED AT HAGENDORF. UPON VISUAL INSPECTION, NICKS/SCRATCHES ARE PRESENT ALL OVER THE DEVICE INDICATING SIGNS OF USE. SIGNS OF DAMAGE ARE PRESENT ON THE HANDLE END SIDE WHERE THE METAL IS DAMAGED BY THE PRESENCE OF DEEP GROOVES (SCRATCHES) (SIMILAR TO THE USE OF PLIERS OR A HAMMER) AND BECAUSE THE END IS NO LONGER STRAIGHT BUT BENT, AND ON ONE EXTREMITY OF THE HEXAGONAL FEATURE WHERE THE MATERIAL IS DEFORMED DUE TO A STRONG FORCE APPLIED ON IT. BASED ON THE VISUAL INSPECTION IS CLEAR THAT THE DEVICE HAS BEEN NOT PROPERLY USED BY APPLYING A STRONG FORCE ON THE PART. MOST LIKELY THE END SIDE WAS GRABBED BY A PLIER TO FORCE THE INCORRECT ASSEMBLY OF THE PART WITH ITS COUNTERPART DEVICE (PN# 03.045.005, LN# 75P8423) (INVESTIGATED SEPARATELY UNDER PL-16318984794415471). THIS ACTION CAUSED THE DAMAGE OF BOTH THE DEVICES. FUNCTIONAL TEST: FUNCTIONAL TESTS WERE PERFORMED ON THE RETURNED DEVICE (PN# 03.045.006, LN# 75P8426) ACCORDING TO INSPECTION SHEET SE_782444 VERSION AA AND PQP SE_736517 VERSION AB. IN PARTICULAR, ACCORDING TO PQP SE_736517_AB, CTQ06 (THREAD ON TIP) AND CTQ07 (LENGTH OF SHOULDER TO TIP) WERE TESTED. THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: GEWINDE M2.5 PH0.9 P0.45-6G USING GEWINDELEHRRINGE WITH ID (GO GAUGE) SW6384 AND (NO GO GAUGE) SW6387. THE DEVICE PASSED THIS TEST. 223.6 ± 0.15 MM USING HOHENMESSGERAT WITH ID NUMBER SW7285. THE RESULT FOUND ON THE DEVICE IS 223.601 MM RESULTING TO BE IN SPECIFICATION AND PASSING THE TEST. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S) UNABLE TO PERFORM, SINCE THE DEVICE WAS SHIPPED WITH SPRING COMPONENT 50101894 AND COMPONENT 60217775 OF THE MATING DEVICE CUT IN HALF. DIMENSIONAL INSPECTION: THE DEVICE 03.045.006 WITH LOT NUMBER 75P8426 IS DAMAGED BY MISHANDLING AND, FOR THIS REASON, A DIMENSIONAL INSPECTION IS NOT PERFORMED. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DOCUMENT(S) (CURRENT AND MANUFACTURED TO) WERE REVIEWED: DEVICE HISTORY RECORD (DHR) 17195253 OF THE ARTICLE 03.045.006-US WITH LOT NUMBER 75P8426 INSPECTION SHEET SE_782444 VERSION AA, "PA INTERN MULTIPLE 03.045.006/-US"; DRAWING SE_716179 VERSION G, "RETENTION PIN SCR.DRIVER W QUICK COUP "; PRODUCT QUALITY PLAN (PQP) SE_736517 VERSION AB, "PQP 03.045.006 & 03.045.008". IN ORDER TO PERFORM THE INVESTIGATION, ALL THE DOCUMENTS MENTIONED ABOVE, VALID WHEN THE DEVICE WAS MANUFACTURED, HAVE BEEN ANALYZED. THE MANUFACTURING PROCESS WAS EXECUTED ACCORDING TO THE ANALYZED DOCUMENTS AND NO ANOMALIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THE COMPLAINT IS BEING CONFIRMED FOR THE RETENT PIN SCRDRIVER QC -HEX 12/ XL25 (PART# 03.045.006, LOT# 75P8426 QTY# 1). THE ROOT CAUSE FOR THE REPORTED ISSUE IS ATTRIBUTED TO USER ERROR FOR MISHANDLING OF THE DEVICE. AS SEEN IN THE PICTURES IN THE REPORT, THE DEVICE (03.045.006) WAS TWISTED 60° AND PUSHED INTO THE HEXAGON OF THE KNOB 60217774 BY FORCE (EVIDENCE OF IMPROPER FORCE APPLIED ARE SHOWN ON THE HANDLING EXTREMITY OF THE DEVICE 03.045.006). THIS CAUSED MATERIAL DEFORMATION OF BOTH THE ARTICLES AND THE IMPOSSIBILITY OF THEIR FURTHER USE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED UPON THESE RESULTS, NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT - PART NUMBER: 03.045.006, LOT NUMBER: 75P8426, MANUFACTURING SITE: HAEGENDORF, RELEASE TO WAREHOUSE DATE: 6 NOVEMBER 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J EMPLOYEE. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON SET REASSEMBLY, IT WAS NOTICED THAT THE SCREWDRIVER, WITH QUICK COUPLING HEXAGONAL, WOULD NOT FULLY MATE WITH THE RETENTION PIN. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) RETENT PIN SCRDRIVER QC -HEX 12/ XL25. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510941 RETENT PIN SCRDRIVER QC -HEX 12/ XL25 SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.045.006 75P8426 10886982292537

    Patients

    Seq Age Sex Outcome Treatment
    1 SCRDRIVER SFT/RETAINING QC HEX 12/ XL25