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Notes to form 3500a and justification for information not provided as required per 21cfr803.52 is below.Trilliant surgical attempted to obtain the omitted information as part of internal complaint handling activities.Patient date of birth and weight not reported.Date of event, with the event being onset of pain, is unknown.Catalog # and serial # not utilized by trilliant surgical.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Lot # and unique identifier (udi) # could not be confirmed.*see note below.Reprocessor name and address n/a to this report.Concomitant medical products and therapy dates not reported.Follow up n/a to this report.Device manufacture date could not be confirmed.*see note below.Removal # n/a to this report.No files attached to this report.*note: because screw length is unknown, brand name and model # feature 'xx' in place of the length measurement.Due to this unknown screw length, lot # and unique identifier (udi) # and device manufacture date could not be confirmed and device history record (dhr) review could not be conducted.Investigation summary: event description: a 4.0mm x xxmm tiger cannulated screw was removed due to pain.During the removal case, there was difficulty in removing the implanted screw, so another removal case was scheduled.During the second removal attempt, doctor 1 successfully removed the screw when utilizing the removal kit and trephine drill.Review of surgical technique: the physician and location of the original implantation are unknown.Thus, there is no available information regarding the surgical technique followed for the implantation case.As described, a trilliant surgical r&d engineer reviewed the x-ray and believed the tiger cannulated screw appeared to be proud.Doctor 1 believes this is the reason the patient was experiencing localized pain.The r&d engineer was interviewed to determine why he believes the screw to be proud.Based on the amount of bone resorption around the screw shown on the x-ray near the screw shaft and threads, the r&d engineer believes the screw has been toggling around in the bone for a while and has backed out over time.There is also the potential that the screw was proud during the original implantation and was inadvertently left as such.However, the x-ray shows that temporary fixation was achieved and the original osteotomy has healed completely.Dhr review: because the physician and location of the original implantation remain unknown, potential lot numbers could not be narrowed down for the tiger cannulated screw.Thus, dhr review cannot be conducted.Visual / dimensional inspection: visual / dimensional inspection could not be conducted due to the removed screw not being returned.Simulated use testing: simulated use testing could not be conducted due to the removed screw not being returned.Simulated use testing will not be performed on a tiger cannulated screw on hand at corporate due to the inability recreate the experienced pain and interaction of the proud screw that resulted in the removal case.Evaluation of similar complaints: the complaints log was reviewed for any events between february 2019 and february 2020 involving a tiger screw removal due to the screw being proud.No complaints were identified as pertaining only to the tiger cannulated screw system.Summary / root cause analysis: the root cause of the removal case is due to the patient experiencing pain from the proud screw.The proud screw may have been a result of the screw being left proud during the original implantation, or it may have been a result of bone resorption and toggling over time.With minimal information regarding the implantation procedure, it cannot be confirmed why the screw is proud.
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On 02/20/2020, the materials manager of doctor 1, dpm's office called in requesting a removal kit for a 4.0mm x xxmm tiger cannulated screw (200-40-0xx).The materials manager stated that the removal is due to the patient reporting pain prior to his post-operative review on (b)(6) 2020.The materials manager stated that the medical record number (mrn) tag / patient record log stated that the patient was a (b)(6)-year-old male that had the tiger screw implanted on (b)(6) 2016.The physician and location of the original implantation remain unknown.The removal will occur with doctor 1 in his clinic at facility x on (b)(6) 2020.Additional information shall be requested post-removal with the materials manager to retain the aforementioned screw and obtain further details regarding the removal.On 02/27/2020, doctor 1 called sales support while the removal was occurring and emailed x-rays for assistance in the removal.Upon viewing the x-rays and discussing removal options with a trilliant surgical r&d engineer, the tiger cannulated screw appeared proud which was what led doctor 1 to believe that was the root cause of the localized pain in the patient.While utilizing the provided removal kit, doctor 1 had difficulty removing the screw because the head looked to be damaged / stripped and would not mate with the provided 3.0/4.0mm cannulated screw driver bit (210-40-003).Doctor 1 was unable to remove the screw in-office and had to reschedule the removal at the surgery center nearby.On (b)(6) 2020, the rescheduled removal occurred at facility x and doctor 1 utilized the same provided removal kit in conjunction with a trephine drill to remove the tiger cannulated screw.Doctor 1 was successful with this method and completed the removal, as desired.On 03/11/2020,sales support followed up with the materials manager to see if the aforementioned screw could be returned to trilliant surgical corporate for further review.As of 03/12/2020, the screw has not been returned.
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