|
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 (items 1-14 below) as part of internal complaint handling activities.Patient age at time of event, date of birth and weight not reported.Outcomes attributed to adverse event is n/a to this report as the event is being reporting for potential to cause harm.Catalog # and serial # not utilized by trilliant surgical.This event includes multiple parts.All related lot #s and unique identifer (udi) #s are listed below.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Date implanted and date explanted are n/a to this report as the device related to this event is an instrument and cannot be implanted.Concomitant medical products and therapy dates not reported.Initial reporter fax not provided.Device pma/510(k) and bla numbers are n/a to this report.Na was not entered within the field for bla number as this caused technicals errors to occur in previous mdr submissions.N/a to this report.All device manufacture dates are listed below.N/a to this report.N/a to this report.No files attached to this report.Investigation: evaluation of similar complaints: the complaints log was reviewed to identify any similar events involving arsenal drills not cutting properly between (b)(6) 2019 and (b)(6) 2020.Seven (7) similar complaints were identified with the following root causes: no identified defect (2), unknown (3), use error (1), and specification/material (1).None of these events contain parts of the same lot number(s) as the reported event.Device history record (dhr) review: 1.2.7mm arsenal screw drill bit (p/n 330-27-001).Lot #tsl009096 [manufactured 01/22/2020, udi (b)(4)] which had no associated nonconformance reports (ncrs) or reworks (rwks).Deviation (dev) 19-0009 was initiated on lot tsl009096 to implement aql sampling plans for class i devices manufactured and / or assembled at trilliant surgical.As aql sampling plans are permissible in application of statistical techniques, sop (b)(4) does not correspond to the reported event.3.5mm arsenal screw drill bit (p/n 330-35-001).Lot #tsl009465 [manufactured 03/09/2020, udi (b)(4)] which had no associated ncrs or rwks.Dev 19-0009 was also initiated on lot tsl009465.In conclusion, there were no identified issues related to the complaint event.Review of surgical technique: arsenal plating system instructions for use, ifu 900-01-019 revision a corresponds to the event.It is documented that the doctor/ user followed the ifu and there are no abnormalities to document.Visual and dimensional inspection: the parts have not yet been returned, so visual and dimensional inspection could not be conducted.Simulated use testing: revision a of the 2.7mm arsenal drill bits has undergone successful testing captured within the arsenal plating system 2.7mm pilot drill test report, (b)(4).The 2.7mm arsenal drill bits met the acceptance criteria, which was to initiate into bone or bone analog with 2.5-4.0lbs axially loaded and to cut greater than or equal to 0.020" into 30 pcf sawbone within 15 revolutions at an axial load of 2.5lbs.Eight (8) samples were tested and found to have an average maximum depth of 0.09425", which exceeds the acceptance criteria requirement.Revision a of the 3.5mm arsenal drill bits has undergone successful testing captured within the arsenal plating system 3.5mm pilot drill test report, (b)(4).The 3.5mm arsenal drill bits met the acceptance criteria, which was to initiate into bone or bone analog with 2.5-4.0lbs axially loaded and to cut greater than or equal to 0.020" into 30 pcf sawbone within 15 revolutions at an axial load of 2.5lbs.Eight (8) samples were tested and found to have an average maximum depth of 0.1184", which exceeds the acceptance criteria requirement.As the parts were not returned, further simulated use testing will not be conducted.The previously referenced test reports shall suffice for documentation of similar parts undergoing simulated use testing.Investigation conclusion: there are no abnormalities documented in regards to the doctor's surgical technique.Because the part was not returned, visual and dimensional inspection could not be performed.As documented above, the 2.7mm arsenal drill bits and the 3.5mm arsenal drill bits have undergone successful testing captured within the arsenal plating system 2.7mm pilot drill test report, (b)(4), and the arsenal plating system 3.5mm pilot drill test report, (b)(4).With the parts not being returned, the root cause of the arsenal drill bits not properly cutting remains unknown.
|
|
On (b)(6) 2020, a trilliant surgical sales representative reported that a 330-27-001 (2.7mm arsenal drill bit) and 330-35-001 (3.5mm arsenal drill bit) performed inadequately during a first mpj procedure also on (b)(6) 2020 at facility 1 with doctor 1.The sales representative stated that doctor 1 was dissatisfied with the cutting performance of both the 330-27-001 and the 330-35-001 that were provided in the sales representative's personal arsenal set.During the procedure on a female patient with hard bone (additional patient details may be obtained when charge form with patient sticker is submitted), doctor 1 stated the drills were "too dull" to cut down to the inner cortex.Doctor 1 utilized three separate drills of both sizes during the procedure and all drills were having the same difficulties with cutting through to the inner cortex.Doctor 1 had to apply additional pressure to cut down to his desired depth and feared that he could potentially drill down and through the bottom of the patient's foot.Once pressure was applied and the drill depth was achieved, the rest of the procedure was successful.The sales representative also wanted to note that he believes the arsenal drills in the set were brand new and were not previously used in cases.He also noted that he believes previous revisions seemed to be sharper.It is to be expected that both the 330-27-001 and 330-35-001 drills will be returned for further review.Quantity of return will remain unknown until receipt as the sales representative is unaware of what drills were kept or discarded by facility 1.
|
|
--additional information provided in follow-up submission b4 d9 g3 g6 h2 h3 h6 - type of investigation (add code 10, remove code 4114), investigation findings (add code 213, remove code 3221) h7 h10 - additional manufacturer narrative --additional investigation conducted (b)(6) 2021: the complaint-related parts were received at trilliant surgical on (b)(6) 2021.-device history record (dhr) review dhr review for the confirmed lot numbers was previously performed within the initial investigation (as documented within customer complaint report (ccr) assessment and investigation, frm qlt-005j, and initial submission for 3007420745-2021-00003).-visual inspection the complaint-related parts were visually reviewed under magnification.The cutting edges of all three drills demonstrated minor aberrations due to wear and tear from usage in the field.There were no major abnormalities observed that would inhibit the drills to cut properly.-dimensional inspection all three drills underwent 100% dimensional inspections.There were no nonconformances identified.-simulated use testing simulated use testing with porcine bone was utilized to evaluate the capability of each drill tested to initiate and not skive off the bone when in use.All complaint-related parts underwent simulated use testing to evaluate if the complaint-related parts can meet the intended user needs (drills shall drill through bone to allow for implant insertion).The acceptance criteria was that each drill shall be able to initiate and drill through cortical and cancellous bone five (5) times, creating a new hole each time.The acceptance criteria was met for each drill (figure 4-5).It is to be noted with the 3.5mm arsenal drill, there was nonoptimal chip evacuation with the flutes.However, the nonoptimal chip evacuation observation was not reported by the sales representative within the complaint event description.The nonoptimal chip evacuation did not impact the ability of the 3.5mm arsenal drill to initiate and not skive off the bone when in use.-root cause / conclusion the event could not be recreated at trilliant surgical.There were no abnormalities to document in regards to visual inspection or dimensional inspection.The root cause shall be identified to "no identified defect".The risk justification remains appropriate.The action shall be updated to include capa 20-011.Capa 20-011 is taking actions towards enhancing drill designs.-disposition the parts shall be scrapped and remain in the complaint folder.No netsuite transactions are necessary as the complaint-related parts were previously reconciled.
|
