BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HPUNI PIN PACK

    MDR report key: 23797647 · Received December 13, 2025

    Report

    Report Number
    1818910-2025-21815
    Event Type
    Malfunction
    Date Received
    December 13, 2025
    Date of Event
    December 1, 2025
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LXH
    UDI-DI
    10603295547860
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED: "SIGMA HP UNI CUTING BLOCK LEFT. PIN GOT STOCK DURING SURGERY IN THE BLOCK." THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION REVEALED THE FOLLOWING CONDITIONS ON THE HPUNI PIN PACK: 1) ONLY TWO OF THE FIVE PINS PACK WERE RETURNED FOR EVALUATION; 2) ONE PIN WAS DELAMINATED AND STUCK ON ONE OF THE HPUNI TIB CUT BLK LMRL'S PIN GUIDES; AND 3) THE OTHER PIN WAS FOUND DEFORMED. PINS HAD SIGNS OF USAGE AND NO OTHER ANOMALY WAS IDENTIFIED ON THEIR SURFACES. DAMAGE OBSERVED ON THE RETURNED PINS WERE CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES SUCH AS DRILLING THE PIN INTO THE GUIDE/HOLE IN AN MISALIGNED POSITION. PROPERLY HANDLING AND¿ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. PLEASE REVIEW THE ASSEMBLY PRECAUTIONS SPECIFIED ON INTUITION TM INSTRUMENTS ¿ SURGICAL TECHNIQUE (227024-230316 EMEA) PAGES 7, 10, 13, 14 AND 33. AS FOR THE MISSING PINS, WITHOUT CONCRETE EVIDENCE OR FURTHER INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST REVEALED ONE OF THE PINS STUCK AND UNABLE TO BE DISENGAGED FROM ITS MATING COMPONENT (HPUNI TIB CUT BLK LMRL). THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE HPUNI PIN PACK WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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: A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR THIS DEVICE. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. ADDED: D9. 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: CORRECTED: D4 (PRIMARY UDI NUMBER). 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). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL MANUFACTURER NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    SIGMA HP UNI CUTTING BLOCK LEFT. THE PIN GOT STUCK DURING SURGERY IN THE BLOCK. NO ISSUE FOR THE PATIENT. SURGERY DELAY 2-5 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484948 HPUNI PIN PACK ORTHOPEDIC INSTRUMENT - FIXATION PIN LXH DEPUY IRELAND - 3015516266 10603295547860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown