BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI STERNAL LOCKING STRAIGHT PLATE 30 HOLES-STERILE

    MDR report key: 7009652 · Received November 8, 2017

    Report

    Report Number
    3003506883-2017-10254
    Event Type
    Injury
    Date Received
    November 8, 2017
    Report Date
    October 11, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A CUSTOMER QUALITY REVIEW WAS PERFORMED AS FOLLOWS: THE COMPLAINT IS CONFIRMED AS THE BREAKAGE IS VISIBLE ON THE RECEIVED PICTURES. THE MANUFACTURING DOCUMENTS OF BOTH INVOLVED DEVICES WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCTS WERE NOT RETURNED, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. THE ROOT CAUSE IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DATE OF EVENT: DATE OF DEVICE BREAKAGE IS NOT KNOWN. ADDITIONAL PRODUCT CODES: HWC, JDQ. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW COMPLETED FOR 460.024S, LOT 5275962, PART MFG DATE: 15SEP2006, PART EXP. DATE: N/A (FOR S PART NUMBERS). NON-STERILE PART 460.024.1, LOT 5275962. (NON-STERILE PART INFORMATION BY CHU) MANUFACTURING LOCATION: (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TI STERNAL LOCKING STRAIGHT PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCE NOTED. THIS LOT 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. THIS RAW MATERIAL LOT 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. REPORT WAS INITIALLY SUBMITTED ON NOV 1, 2017, BUT THE FDA SITE WAS DOWN. ADVISED BY FDA ON NOV 8, 2017 TO RESUBMIT MEDWATCH. 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

    UDI# (B)(4). ADDITIONAL LOT# 5341893. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 460.024S, LOT# 5341892. MANUFACTURING LOCATION: ELMIRA, MANUFACTURING DATE: SEP 26, 2006, EXPIRY DATE: AUG 31, 2015. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THIS LOT 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. THE REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS. THE RAW MATERIAL LOT 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 · 1

    THE PLATES BROKE POST-OPERATIVELY SO WHEN REMOVING/RETRIEVING THEM THEY DETECTED THAT THE PLATES WERE ALREADY BROKEN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE IMPLANTS SNAPPED IN SITU, (THE (2) PLATES WERE BROKEN/SHEERED APART ON RETRIEVAL). REMOVAL SURGERY WAS DONE. NO FURTHER INFORMATION AT THE MOMENT. TWO PLATES HAD FAILED. AND THE PATIENT WAS RETURNED TO SURGERY ON AUGUST 3, 2017 WHERE ALL HARDWARE WAS REMOVED. THERE IS NO ALLEGATION AGAINST THE SCREWS. THE REMOVAL SURGERY WAS SUCCESSFUL AND NOT DELAYED. THE IMPLANTS COULD BE REMOVED EASILY. THIS COMPLAINT INVOLVES 2 PARTS. CONCOMITANT PARTS: UNILOCK SCREW: (PART: 04.501.112S / LOT: 3814387 / QUANTITY 9); UNILOCK SCREW: (PART: 04.501.112S / LOT: 3799295 / QUANTITY 3 ); UNILOCK SCREW: (PART: 04.501.112S / LOT: 79564673 / QUANTITY 10 ) LOT # SHOULD BE 7 DIGITS. LOT UNK.; UNILOCK SCREW: (PART: 04.501.112S / LOT: 3814382 / QUANTITY 1 ); UNILOCK SCREW: (PART: 04.501.112S / LOT: 7564672 / QUANTITY 1 ); UNILOCK SCREW: (PART: 04.501.112S / LOT: 3799297 / QUANTITY 1 ); UNILOCK SCREW: (PART: 04.501.112S / LOT: 3814385 / QUANTITY 1 ). THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789368 TI STERNAL LOCKING STRAIGHT PLATE 30 HOLES-STERILE PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 5341892

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKING SCREW (04.501.112S, LOT 3799295, QTY 3),| LOCKING SCREW (04.501.112S, LOT 3799297, QTY 1),| LOCKING SCREW (04.501.112S, LOT 3814382, QTY 1),| LOCKING SCREW (04.501.112S, LOT 3814385, QTY 1).| LOCKING SCREW (04.501.112S, LOT 3814387, QTY 9),| LOCKING SCREW (04.501.112S, LOT 7564672, QTY 1),| LOCKING SCREW (04.501.112S, LOT 79564673, QTY 10),