BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP SZ. 30 PROXIMAL

    MDR report key: 6937209 · Received October 10, 2017

    Report

    Report Number
    1651501-2017-00039
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 20, 2017
    Report Date
    February 3, 2025
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    OMX
    PMA / PMN Number
    H010005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD G6. PREVIOUS FOLLOW-UP SUBMITTED ON 11/20/2017 AS FOLLOW-UP #2. CORRECTED FIELD WAS UPDATED TO FOLLOW-UP #1.

    Additional Manufacturer Narrative · 0

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON OCTOBER 20, 2017. RESULTS: EVALUATION OF RETURNED DEVICE; THE COMPLAINT PART WAS RETURNED. THE ARTICULATING PORTION OF THE PART WAS RETURNED IN A CANISTER WITH THE PART LOOSE; HOWEVER, THE STEM WAS NOT RETURNED. BASED ON THE VISUAL ANALYSIS PERFORMED, THE FAILURE MODE OF THE PART COULD NOT BE DISCERNED; HOWEVER, THE FRACTURE APPEARANCE IS CONSISTENT WITH A RAPID BRITTLE, BENDING FRACTURE. STEM FRACTURES ARE KNOWN TO OCCUR UPON IMPACT USED TO SEAT THE PROSTHESIS DURING SURGICAL IMPLANTATION INTO AN INCOMPLETELY BROACHED MEDULLARY CANAL. CONCLUSION: WHILE THE PART WAS RETURNED AND FAILURE WAS CONFIRMED, NO ROOT CAUSE COULD BE DETERMINED. POSSIBLE CAUSES INCLUDE UNSUPPORTED IMPACTING AND INCORRECT OBLIQUE CUT OR BROACHING DIRECTION.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON OCTOBER 4, 2017. RESULTS: DHR REVIEW; REVIEW OF MANUFACTURING RECORDS SHOWED NO EVIDENCE OF A NONCONFORMANCE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. COMPLAINTS HISTORY; A SEARCH OF THE RESULTS OF THE SHORT DESCRIPTION FIELD CONTAINING ¿PIP¿ SEPTEMBER 2015 TO PRESENT SHOWED 11 COMPLAINTS OF INTRA-OPERATIVE PIP FRACTURES, INCLUDING THIS ONE. (B)(4). CONCLUSION: THE PART HAS NOT BEEN RETURNED TO DATE; THEREFORE, NO ROOT CAUSE CAN BE DETERMINED. POSSIBLE CAUSES INCLUDE UNSUPPORTED IMPACTING AND INCORRECT OBLIQUE CUT OR BROACHING DIRECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD SUCCESSFULLY IMPLANTED BOTH IMPLANTS DURING A RIGHT AND MIDDLE FINGER PIP ARTHROPLASTY. AS HE BEGAN TO ASSESS THE RANGE OF MOTION OF THE IMPLANT, THE HEAD OF THE PROXIMAL IMPLANT (PIP-200-30P-WW, LOT 163564T) ROLLED OUT OF THE PATIENT WITH THE STEM OF THE IMPLANT STILL EMBEDDED. IT WAS REPORTED THAT THIS INCREASED SURGERY TIME QUITE DRAMATICALLY: INITIALLY A 70MIN PROCEDURE, THE SURGERY ENDED UP BEING A 3 HOUR 40MIN PROCEDURE. DUE TO BREAKAGE, THE STEM OF THE IMPLANT WAS DIFFICULT TO REMOVE, RESULTING IN THE ADDITIONAL REAMING. THIS RESULTED IN USING LARGER SIZED IMPLANTS: THE SURGEON RESORTED TO USING LARGER SIZE IMPLANTS (40P & 30D) THAT WERE IMPLANTED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714251 PIP SZ. 30 PROXIMAL PIP OMX ASCENSION ORTHOPEDICS 163564T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PIP-200-20D (PIP SZ. 20 DISTAL) LOT # 171350T