BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-STEM NECK RESECTION CALIPER

    MDR report key: 24136413 · Received January 21, 2026

    Report

    Report Number
    1818910-2026-01281
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    January 12, 2026
    Report Date
    January 21, 2026
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KTZ
    UDI-DI
    10603295251422
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: MISSING PART. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. PHOTOS WERE PROVIDED TO DEPUY SYNTHES FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT THE C-STEM NECK RESECTION CALIPER HAS ITS LOCKING SCREW MISSING. NO OTHER ANOMALIES WERE OBSERVED ON THE PHOTOS PROVIDED. MISSING COMPONENTS CONDITION MAY OCCUR DURING THE CLEANING/STERILIZATION PROCESS, PARTICULARLY WHEN THE COMPONENTS ARE ASSEMBLED OR DISASSEMBLED. AS THESE PROCEDURES ARE OFTEN REPEATED, THERE IS AN INCREASED RISK OF COMPONENTS GOING MISSING. HOWEVER, WITHOUT CONCRETE EVIDENCE OR FURTHER INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE C-STEM NECK RESECTION CALIPER WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: MISSING PART. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE C-STEM NECK RESECTION CALIPER HAS ITS LOCKING SCREW MISSING. NO OTHER ANOMALIES WERE NOTED. MISSING COMPONENTS CONDITION MAY OCCUR DURING THE CLEANING/STERILIZATION PROCESS, PARTICULARLY WHEN THE COMPONENTS ARE ASSEMBLED OR DISASSEMBLED. AS THESE PROCEDURES ARE OFTEN REPEATED, THERE IS AN INCREASED RISK OF COMPONENTS GOING MISSING. HOWEVER, WITHOUT CONCRETE EVIDENCE OR FURTHER INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE C-STEM NECK RESECTION CALIPER WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORM. CORRECTED: H3.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D9 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). 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. 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

    IT WAS REPORTED THAT DURING A LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN, THE C STEM NECK RESECTION CALIPER WAS FOUND TO HAVE A MISSING PART. NO SURGEON, PROCEDURE, OR PATIENT DETAILS ARE AVAILABLE AND NO FURTHER INFORMATION CAN BE OBTAINED BECAUSE THE CUSTOMER DID NOT REPORT THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17300 C-STEM NECK RESECTION CALIPER HIP INSTRUMENTS : SIZING/MEASURING INSTRUMENTS KTZ DEPUY ORTHOPAEDICS INC US CL2645907 10603295251422

    Patients

    Seq Age Sex Outcome Treatment
    1