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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 age at time of event, date of birth and weight are unknown.Required intervention to prevent permanent impairment/damage was selected within outcomes attribute to adverse event referring to the doctor's intervention requiring the patient to wear a walking boot.Date of event is unknown.The event is considered to be when the patient started to experience pain.This pain was reported to have occured two (2) months post-op, but implantation date is unknown.Catalog # and serial # not utilized by trilliant surgical.Lot # and unique identifier (udi) # are unknown.See explanation in device history record (dhr) section below.Expiration date not applicable (n/a) to non-sterile trilliant surgical products.Implanted date is unknown.Explanted date is n/a to this report.Concomitant medical products and therapy dates not reported.Initial reporter facility address and fax not reported.Device bla number is n/a to this report.Na was not entered within this field as this caused technical errors to occur in previous mdr submissions.Device manufacture date is unknown.Investigation: evaluation of similar complaints.The complaints log was reviewed to identify any similar events involving cysts forming following implantation of sniper staple implant between october 2019 and october 2020.Two (2) similar complaints were identified with unknown root causes.Neither of these events could be confirmed to be from the same lot number as the reported event.Dhr review: dhr review was not conducted as part / lot number(s) are unknown or could not be narrowed down.As part of the investigation, the applicable sales representative's inventory was reviewed for p/n: 500-10-101.More than ten (10) unique potential lots were identified.In accordance with lot number investigation for customer complaint reports (ccr), wi-0105 revision 2, the identified lot numbers do not need to be evaluated through dhr review as more than ten unique potential lot numbers are less definite and significant to aiding in the complaint investigation for the device in the reported event.Review of surgical technique: sniper staple system, non-sterile instructions for use, ifu 900-01-017 revision c corresponds to the event.Limited information was provided for the surgical technique / conformance to the ifu, so it is unknown if the physician / user was described to have followed the ifu.Note: though doctor 1 discussed post-operative instructions in detail, there was limited information provided regarding surgical technique during the implantation procedure.Visual and dimensional inspection: no parts were returned, so visual and dimensional inspection could not be conducted.Simulated use testing: due to the nature of the event (cyst forming following months after implantation), simulated use testing could not be utilized in attempt to recreate the observation.Investigation conclusion: no patient noncompliance was reported.Similar (b)(4) (mdr report 3007420745-2020-00045) and (b)(4) (mdr report 3007420745-2020-00047) were also from doctor 1 reporting the same observation.Dhr review was not conducted as there were more than ten unique potential lot numbers, making the potential lot numbers less definite and significant to aiding in the complaint investigation for the device in the reported event.The parts were not returned and could not be evaluated.It remains unknown if there were any abnormalities in regards to doctor 1's surgical technique when performing the implantation procedure.If the following conditions are maintained throughout surgery, the incident of aseptic necrosis is unlikely: "preservation of blood supply to maintain viability of the capital fragment, preservation of adherent soft tissues.[and] maintenance of good bone apposition." (1) osteotomies are known to have the potential for disrupting "intraosseous blood flow".(2) the definitive root cause of the disrupted blood flow that resulted in the formation of the bone cyst remains unknown based on the limited information available.However, there are suspected contributing factors: the patient was identified to have multiple pieces of hardware implanted as identified on the provided x-rays.There is potential of the patient having a sensitivity to the material used for the sniper staples, nitinol.However, doctor 1 made no mention to any sensitivities.There is potential of the sniper staple exerting excessive compression on the bone over time following implantation.However, it is known (via phone call with doctor 1's sales representative on (b)(6) 2020 as documented on the activity log within (b)(4)) that doctor 1 utilizes the sniper staple pilot drill guide when implanting any sniper staples.Utilizing the sniper staple pilot drill guide ensures that the compression of the sniper staple being implanted is appropriate as the products in the system were designed to support the user need of the "staple should provide compression" in accordance with the staple design matrix, df-004-0001.The user need of the "staple should provide compression" has been verified in the non-sterile sniper staple verification analysis, (b)(4) and validated in the sniper staple validation report, (b)(4).Thus, the system was designed to provide compression.As there have been no similar complaints that have identified excessive compression resulting in a cyst, the root cause remains unknown.The facility that doctor 1 performed the implantation procedure is unknown.Furthermore, it is unknown if there were any abnormalities that occurred when the system underwent sterilization at the facility that may have pertained to the irritation that was observed surrounding the implant and resulted in a cyst.Doctor 1 nor the sales representative made no mention to any abnormalities during the sterilization process at the facility.The sterilization capabilities of the non-sterile staple tray have been verified in the non-sterile sniper staple verification analysis, (b)(4), and validated in the non-sterile sniper staple system pre-vacuum sterilization and dry time validation study, (b)(4).Thus, the system was designed to be suitable for steam sterilization at a facility.Though suspected contributing factors were identified above, there are no confirmed root causes at the time of this investigation.The root cause remains unknown.The risk of the event is evaluated below.However, it is noteworthy that doctor 1 is the first doctor to report any cysts forming following the implantation of a sniper staple.Doctor 1 confirmed that union had occurred and the patient was not experiencing pain after continuing to wear the boot for extended time post-operatively.The root cause of the cyst formation following implantation remains unknown.It was determined that (b)(4) sniper staples (non-sterile and sterile) were sold between october 2019 and october 2020.With only three total reported events from only doctor 1 [(b)(4) (mdr report 3007420745-2020-00045), (b)(4) (mdr report 3007420745-2020-00047), (b)(4)], the occurrence rate is (b)(4).There were suspected contributing factors pertaining to patient sensitivity to nitinol, excessive compression, and sterility.All of which are captured on the sniper staple risk matrix, rf-001-0001 revision 9, and were evaluated.The occurrence level and detection level shall remain as is for all of the following evaluations as the complaint cannot be confirmed to be pertaining to any of the following risks.The severity level was evaluated in the following: ufmea 2.0 captures the risk of a patient having an identified allergy or sensitivity to nickel-titanium alloy.Severity level of 4 (significant) would be appropriate as a removal case would be necessary.In this instance, a removal case occurred but it cannot be confirmed if it was resulting from the patient having a nitinol sensitivity.Dfmea 3.1 captures the risk of the staple overcompressing the osteotomy.Severity level of 4 (significant) would be appropriate as a removal case would be necessary.In this instance, a removal case occurred but it cannot be confirmed if it was resulting from the staple overcompressing the osteotomy.The effect of dfmea 3.1 states "incomplete fixation".Ufmea 5.6 captures the risk of the system being utilized in a non-sterile environment.Severity level of 5 (severe) would be appropriate as a removal case would be necessary.In this instance, a removal case occurred but it cannot be confirmed if it was resulting from the system being utilized in a non-sterile environment.The observation of a cyst forming following the implantation of a sniper staple will continue to be monitored through the complaint intake process.References: (1) bouchard, j.L.(1989).Aseptic necrosis foilowing distal osteotomies of the first metatarsal.Retrieved november 02, 2020, from http://www.Podiatryinstitute.Com/pdfs/update_1989/1989_03.Pdf.(2) edwards, w.H.(2005).Avascular necrosis of the first metatarsal head.Foot and ankle clinics, 10(1), 117-127.Doi:10.1016/j.Fcl.2004.11.001.
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On 10/14/2020, a conference call was conducted via zoom with doctor 1 in response to his comment on trilliant's 2020 products & services survey regarding trilliant's non-sterile sniper staple system "cause(ing) large proximal phalanx bone cyst formation threat require(ing) bone filler replacement." the response was originally recorded in (b)(4) (mdr report 3007420745-2020-00045).Due to the nature of the report during the call (b)(4) (mdr report 3007420745-2020-00047) and (b)(4) have been initiated to report the individual patients discussed during the meeting.A trilliant surgical sales support specialist, quality engineer, associate r&d engineer, and product manager were in attendance during the call.This ccr captures information over the third of the three patients reviewed during that call.Doctor 1 implanted a 500-10-101 (10mm x 10mm x 10mm staple) for an akin osteotomy on a patient somewhere in the 40-50-year-old age range (dob: unknown) female, weight unknown, with reported good bone quality.The patient has no reported comorbidities and no non-compliance was reported.Doctor 1 performed the akin osteotomy following a bunion correction by fixation with a lapidus plate, to be confirmed when case detailed are confirmed.At this time the date of implantation, facility the procedure occurred at, and the patient's date of birth, age, and weight is unknown.Doctor 1 has been followed up with in the below email to obtain the missing information that was not available during the call."hi dr.[x].Thank you again for taking time out of your day to discuss what trend you're seeing arise with implanting our 10mm staples within trilliant's "non-sterile" staple trays for akin procedures.I found the call extremely beneficial.Please do not hesitate to reach out to me if you see any further trends, have any suggestions, and/or questions/concerns.I've provided below the follow up questions we discussed so our team can work with a timeline of events for each of the patients discussed in the zoom call today.Please let me know if you're unable to obtain the information and i'll report with just the information we collected from the call! i know you mentioned the third patient discussed was quite some time ago, again, just provide information that you can patient one ((b)(6), female): hospital/surgery center the case took place at: patient date of birth: date of original implantation: date patient reported the localized pain: date of revision procedure: patient two ((b)(6), female): hospital/surgery center the case took place at: patient date of birth: date of original implantation: date patient reported the localized pain: date of revision procedure: patient three (middle aged, female): hospital/surgery center the case took place at: patient date of birth: patient age: patient weight: date of original implantation: date patient reported overall foot pain: thank you," a few months post-op, doctor 1 reported he heard from the patient that she was reporting pain throughout the whole area of the foot where surgery was performed.Doctor 1 found that was staple implanted was not broken and surgical intervention was not required to address the patient's pain.The complaint of pain was resolved by putting the patient in a walking boot.Please note this was the first patient doctor 1 identified the cyst forming with.However, he was unsure of what was occurring as he had not seen it before.By speculation, doctor 1 believes the staple reached its endpoint of compressing and the patient got over the pain by utilizing the walking boot.Additional information 10/20/2020: "email follow up made over previous email.Dr.[x] replied saying he was working on obtaining the information still." additional information 10/21/2020: "no additional information could be obtained by dr.[x].This was confirmed via phone conversation with dr.[x] and this confirms a good faith effort to obtain additional information." additional information 10/21/2020: "union did occur in the proximal phalanx at the site of implantation per dr.[x]".
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