PROSTHESIS 0520 FLEX H/A NOTCHED OFFSET

[2404184] It was reported that during a scheduled surgery involving a middle ear prosthesis the, "implant was put into the ear and as (it was) being placed into position it came apart into two pieces. Both of the pieces were located and were removed from the ear. " another prosthesis was implanted without incident. There was no report of patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5

[9692459] (b)(4). Multiple attempts to obtain the required information were made, and the records of these attempts are documented in the complaint file. This product was being used for treatment, not diagnosis. The device has not been returned. Neither applicable imaging films nor medical records were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. The report is inconclusive as to the cause of the reported product problem. Without information to reasonably suggest a serious injury or medical intervention was required to preclude serious injury, we are filing this report as a product problem. The information reasonably suggests that a device in question has malfunctioned as defined by the fda and a review of the complaint history indicates that this product issue is likely to cause or contribute to serious injury if this event were to recur. Without serious injury or intervention, we are filing this report as a product problem. The ossicular prostheses, when surgically implanted in the middle ear as individual replacements for the incus, malleus or stapes or for the entire ossicular chain to facilitate the mechanical transfer of sound energy from the tympanic membrane to the oval window of the cochlea. The mechanism of sound energy transfer performed by ossicular prostheses is analogous to that of the natural ossicles of the middle ear. The ossicular prostheses are available in numerous designs and sizes, emulating the bones of the middle ear to satisfy individual patient needs and surgical techniques in the function reconstruction of all or part of the ossicular chain. A variety of biocompatible materials are used in the manufacture of these ossicular prostheses. A high degree of surgical skill is required for the proper implantation of any ossicular prostheses. Surgeon's performing middle ear surgery should have received specific training in the reconstruction and replacement of the middle ear ossicles prior to attempting implantation of the ossicular prostheses. Extreme caution must be exercised by the surgeon during surgery to safeguard against undesirable results and postoperative complications. To prevent potential separation of the shoe component (if applicable), verify prosthesis shaft is fully seated within the shoe prior to placement.
Patient Sequence No: 1, Text Type: N, H10

[9958445] Returned to manufacturer-march 26, 2012. Evaluation conducted on april 2, 2012: this middle ear prosthesis was returned after it separated into two pieces during implantation. The part has separated at the interface between the ha pin and the titanium cup. It has been found that the pin trim depth is substantially less then designed. It is expected that the strength of this joint will be below the as-designed value. In addition to the reduction in the mechanical interaction between the pieces, there will be less adhesion from the epoxy as the entire end surface cannot come into contact with the bottom of the cup. As such, the incorrect pin depth is the most likely reason that this part has failed.
Patient Sequence No: 1, Text Type: N, H10