BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 20MM

    MDR report key: 7310531 · Received March 2, 2018

    Report

    Report Number
    8030965-2018-51658
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    January 30, 2018
    Report Date
    January 31, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH 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. POSSIBLE LOT NUMBERS ARE 9703192 OR 9920342. POSSIBLE UDI (B)(4), EXPIRATION DATE 10/1/2025 OR POSSIBLE UDI (B)(6), 9920342 EXPIRATION DATE 4/1/2026 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 · 0

    DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART: 412.820S , LOT: 9920342 , MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 27. APRIL 2016 , EXPIRY DATE: 01. APRIL 2026 . NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE REVIEW IS WAS FOUND THAT THIS SCREW WAS MADE OUT OF BLANK 412.820.999 WITH LOT 9953382, AN ADDITIONAL DHR ACTIVITY WILL BE LAUNCHED FOR THE BLANK FROM MONUMENT. MANUFACTURING LOCATION: (B)(4), RELEASED TO BP55 - 20-NOV-2015 , PART #: 412.820.999, LOT#: 9953382 (NON-STERILE) ¿ 2.8MM TI SCREW BLANK 20MM 02.4 LOCKING SCREW W/SD8. QTY: 850. COMPONENT PART: 04.210.120.999 - 2.8 MM SCREW BLANK 31MM LOT: 9899733 MEET SPECIFICATION. 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. PART: 412.820S, LOT: 9703192 , MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 03. NOV. 2015 , EXPIRY DATE: 01. OCT. 2025 . NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE REVIEW IS WAS FOUND THAT THIS SCREW WAS MADE OUT OF BLANK 412.820.999 WITH LOT 9885449, AN ADDITIONAL DHR ACTIVITY WILL BE LAUNCHED FOR THE BLANK FROM MONUMENT. MANUFACTURING LOCATION: (B)(4), RELEASED TO BP55 - 19-AUG-2015, PART #: 412.820.999, LOT#: 9885449 (NON-STERILE) ¿ 2.8MM TI SCREW BLANK 20MM 02.4 LOCKING SCREW W/SD8. QTY: 960. COMPONENT PART: 04.210.120.999 - 2.8 MM SCREW BLANK 31MM LOT: 9874213 MEET SPECIFICATION. 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE EVALUATION HAS SHOWN THAT THE BROKEN LOCKING SCREW IS BASED ON THE DIMENSIONS THE PART 412.820, DUE THIS FINDING IS WAS POSSIBLE TO NARROW DOWN THE AFFECTED LOT NUMBERS TO LOT 9920342 OR 9703192. WE FOUND THAT THE HEAD IS BROKEN OFF AT THE CROSSOVER FROM THE SHAFT TO THE HEAD AS COMPLAINED. THE LOCKING THREAD HAS EVEN WEAR MARKS AND IS IN A GOOD CONDITION, NO DAMAGES ARE VISIBLE, WHICH INDICATES THAT THE DEVICE WAS LOCKED IN THE PLATE AS REQUIRED. THERE ARE SLIGHT DEFORMATIONS AT THE STARDRIVE RECESS VISIBLE, WHICH INDICATES THAT FORCE WAS APPLIED ONTO THE SCREW. THE UPPER THREAD FLANKS OF THE SHAFT ARE STRONGLY DAMAGED, MOST LIKELY CAUSED DURING THE REMOVAL OF THE SHAFT AFTER THE HEAD WAS BROKEN OFF. DUE TO THIS DAMAGE AND THE PLACE OF THE BREAKAGE THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE. THEREFORE, THE MANUFACTURING DOCUMENTS OF THE POTENTIAL LOT NUMBERS WERE REVIEWED. NO DEVIATION REGARDING MATERIAL OR DIMENSIONS WAS FOUND. THE COMPLAINT HISTORY WAS REVIEWED AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS PART- AND LOT COMBINATIONS, NEITHER LOT 9920342 NOR LOT 9703192. THE MICROSCOPIC VIEW HAS SHOWN THAT THE FRACTURE FACE IS HOMOGENEOUS WHICH INDICATES MATERIAL CONFORMITY. ALL THESE FINDINGS AND THE FACT THAT THE HEALING PROCESS WAS COMPLETED WITHOUT ANY ISSUES SPEAKS AGAINST A MANUFACTURING RELATED ISSUE. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS BREAKAGE. THE RECEIVED X-RAYS SHOW THE INTACT PLATE AND THE INTACT SCREWS AT UNKNOWN DATES IN DIFFERENT HEALING STAGES. IT IS UNKNOWN HOW LONG THE IMPLANTS WERE IMPLANTED. AT THIS POINT, IT IS LIKELY THAT THE SCREW WAS WEAKENED AFTER THE COMPLETED HEALING PROCESS AND DID THEREFORE BREAK DURING THE REMOVAL. 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. 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

    UPDATE: THE UNKNOWN SCREWS HAS BEEN ADDED AFTER THE INVESTIGATION TO 412.820S, LOT 9703192 OR 9920342.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODES: HWC. POSSIBLE LOT#S ARE 9703192 OR 9920342. (B)(4). DATE OF IMPLANT IS UNKNOWN. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN EXPLANT SURGERY FOR DISTAL RADIUS FRACTURE. DURING THE SURGERY, WHEN THE SURGEON TRIED TO REMOVE A LOCK SCREW FROM THE 2ND MOST DISTAL HOLE ON THE RADIUS SIDE WITH A DRIVER, IT BROKE BENEATH THE SCREW HEAD. AFTER THE SURGEON EXPLANTED VA TCP PLATE (04.111.631S), SURGEON REMOVED THE REMAINING SCREW AND FRAGMENT, AND COMPETED THE SURGERY WITH A TEN-MINUTES DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND THE FRACTURED BONES SHOWED BONE HEALING WITHOUT DEFORMATION. SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 3H (PART# 04.111.631S, LOT# 3948753, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 20MM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153215 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 20MM PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1