BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: HOOK CLAVICLE

    MDR report key: 20788100 · Received November 26, 2024

    Report

    Report Number
    8030965-2024-14370
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    September 13, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (B)(4) GTIN IS NOT AVAILABLE. 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

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHEN PH, CHEN CY, LIN KC, TARNG YW. FIXING CHO TYPE IIC DISTAL CLAVICLE FRACTURES WITH HOOK PLATES LEADS TO A HIGH INCIDENCE OF SUBACROMIAL OSTEOLYSIS: A RETROSPECTIVE STUDY AND LITERATURE REVIEW. CLIN ORTHOP SURG. 2024 OCT;16(5):694-701. DOI: 10.4055/CIOS24009. EPUB 2024 SEP 13. PMID: 39364106; PMCID: PMC11444942. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE STUDY AIMS TO INVESTIGATE WHETHER DIFFERENT FRACTURE CLASSIFICATIONS TREATED WITH HPS RESULT IN DISTINCT COMPLICATION RATES, PARTICULARLY FOCUSING ON THE INCIDENCE OF SAO. BETWEEN JANUARY 2015 AND DECEMBER 2022, A TOTAL OF 91 PATIENTS WERE INCLUDED IN THE STUDY. SAO GROUP CONSIST OF (31 MALE AND 26 FEMALE) WITH A MEAN AGE OF 45.75 ± 16.03 WHILE NON-SAO GROUP CONSIST OF (16 MALE AND 18 FEMALE) WITH A MEAN AGE OF 45.06 ± 15.96. THESE PATIENTS UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION BY USING HP MANUFACTURED BY A SINGLE COMPANY (DEPUY SYNTHES). PATIENTS WERE FOLLOWED-UP ACCORDINGLY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES, HOOK PLATE (HP) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK- CONSTRUCT: CLAVICLE HOOK PLATE/SCREWS (QTY 99) -1 PATIENT WITH CHO TYPE IIB, 3 PATIENTS WITH CHO TYPE IIC AND 1 PATIENT WITH CHO TYPE IID HAD MALUNION. -3 PATIENTS WITH CHO TYPE IIB AND 4 PATIENTS WITH CHO TYPE IIC HAD NONUNION. -4 PATIENTS WITH CHO TYPE IIC HAD LOSS REDUCTION -1 PATIENT WITH CHO TYPE IIB AND 4 PATIENTS WITH CHO TYPE IIC HAD IMPINGEMENT. -2 PATIENTS WITH CHO TYPE IIB, 2 PATIENTS WITH CHO TYPE IIC AND 1 PATIENT WITH CHO TYPE IID HAD ACROMION PERFORATION. -4 PATIENTS WITH CHO TYPE IIB, 7 PATIENTS WITH CHO TYPE IIC AND 3 PATIENTS WITH CHO TYPE IID HAD DISTAL CLAVICLE OSTEOLYSIS. -2 PATIENTS WITH CHO TYPE IIC HAD CLAVICLE MIDSHAFT PERI-IMPLANT FRACTURE. -14 PATIENTS WITH CHO TYPE IIB, 33 PATIENTS WITH CHO TYPE IIC AND 10 PATIENTS WITH CHO TYPE IID HAD SUBACROMIAL OSTEOLYSIS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: LCP CLAVICLE HOOK PLATE (QTY 1) -A 66-YEAR-OLD MAN PRESENTED WITH A CHO TYPE IIC DISTAL CLAVICLE FRACTURE WHO HAD TREATED USING A HOOK PLATE. DURING FOLLOW-UP, THERE WAS PROGRESSION OF SUBACROMIAL OSTEOLYSIS, CULMINATING IN EVENTUAL ACROMION CUT-THROUGH. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: HOOK CLAVICLE (QTY 1) -A 66-YEAR-OLD MAN PRESENTED WITH A CHO TYPE IIC DISTAL CLAVICLE FRACTURE WHO HAD TREATED USING A HOOK PLATE. DURING FOLLOW-UP, THERE WAS PROGRESSION OF SUBACROMIAL OSTEOLYSIS, CULMINATING IN EVENTUAL ACROMION CUT-THROUGH. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - PLATES: LCP CLAVICLE HOOK PLATE (QTY 1) -A 44-YEAR-OLD MAN PRESENTED WITH A CHO TYPE IIC DISTAL CLAVICLE FRACTURE WHO UNDERWENT TREATMENT WITH A HOOK PLATE. POSTOPERATIVE PROGRESSIVE SUBACROMIAL OSTEOLYSIS WITH UPPER MIGRATION OF THE HOOK INTO THE ACROMION WAS IDENTIFIED. ACROMION PERFORATION ACCOMPANIED BY PERI-IMPLANT FRACTURE WAS NOTED AT POSTOPERATIVE 5 MONTHS OF FOLLOW-UP. EVENTUALLY, THE PLATE HAD TO BE REMOVED DUE TO THE DEVELOPMENT OF SEVERE PAIN. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: HOOK CLAVICLE (QTY 1) -A 44-YEAR-OLD MAN PRESENTED WITH A CHO TYPE IIC DISTAL CLAVICLE FRACTURE WHO UNDERWENT TREATMENT WITH A HOOK PLATE. POSTOPERATIVE PROGRESSIVE SUBACROMIAL OSTEOLYSIS WITH UPPER MIGRATION OF THE HOOK INTO THE ACROMION WAS IDENTIFIED. ACROMION PERFORATION ACCOMPANIED BY PERI-IMPLANT FRACTURE WAS NOTED AT POSTOPERATIVE 5 MONTHS OF FOLLOW-UP. EVENTUALLY, THE PLATE HAD TO BE REMOVED DUE TO THE DEVELOPMENT OF SEVERE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368658 UNK - SCREWS: HOOK CLAVICLE SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention