(b)(4).Two (2) vsp bone screws no cut [product code: 2223-2840, lot numbers: m1d98 and m1r65], were returned to the complaint handling unit (chu) for evaluation.Analysis of the screws¿ cut surfaces revealed that there were burrs, which are raised / extra material, present of the surfaces of these screws.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.A root cause for the threads of the locking caps peeling from the nut cannot be positively determined.It was observed that there were burrs present on the cut surfaces of the bone screws.The burring was most likely caused when the screws were cut during the initial surgery.The screws are placed in the spine and the tapered nuts along with the locking nuts are placed over the screws.The screws are then cut to shorten the overall length.When the surgeon went to remove the screws from the patient postoperatively, the burrs could have potentially nicked and sheared off the threads of the locking nuts.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
On (b)(6) 2015, the removal surgery of vsp implanted at other facility (l5-s1) was performed.During the final irrigation of the surgical site, a metal fragment was found.The irrigation was done in the surgical site and the procedure was completed without delay.The surgeon suspected that it was a metal fragment from the implants caused by abrasion at the removal.He strongly requested the investigation and the return of the metal piece and implants.Complaint is a reportable malfunction.(b)(4).Decision tree is reassessed and complaint determined to be reportable based on evaluation of returned product.Device was returned for examination.During device investigation on (b)(6) 2015, investigator noted burrs on the device.There was no report of any adverse consequences to a patient or surgical delay.However, intra-operative breakage of hardware/torn threads has been known to result in a delay of more than thirty minutes and/or a portion of the broken hardware/torn threads remaining in a patient.
|