Model Number 204-30-028 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Unspecified Infection (1930); Post Operative Wound Infection (2446)
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Event Date 12/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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Event description: an event was reported on 12/09/19 stating that a two step hammer toe implant needed to be removed due to patient noncompliance causing an infection.No other details have been provided as of 01/06/2020.An mdr report shall be submitted on 01/06/2020, in accordance with internal reporting procedures.Multiple contact attempts have been made, and the reporter has stated they would details by 01/10/2020.The status shall be monitored in scheduled ccr meetings.A follow up mdr shall be submitted within appropriate reporting requirements upon receipt, as applicable.Multiple contact attempts have been made, and the reporter has committed to provide details by 01/10/2020.Review of surgical technique: patient noncompliance was reported as the cause of the infection.Dhr review: the lot number cannot be determined at this time as the part number and date of implantation is unknown at this time.Visual / dimensional inspection: a visual and dimensional inspection cannot be completed at this time as the part was not returned.Simulated use testing: simulated use testing cannot be completed due to the nature of the complaint.Evaluation of similar complaints: the customer complaints log was reviewed for the past 12 months and identified 1 similar complaint, ccr (b)(4) where 3 two-step (two 204-24-012 and one 204-24-014) hammer toe implant was removed from a patient due to a non-union.The parts were returned for evaluation and no discrepancies were identified.The root cause was unknown.Summary / root cause analysis: the limited investigation identified that patient noncompliance, as stated by the event reporter, is the likely cause of the infection leading to the hardware removal.Additional details shall be considered and submitted in a follow up mdr submission if provided.One similar event was identified in the past 12 months, the field shall be monitored.
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Event Description
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On (b)(6) 2019 (b)(6) emailed in (email received by sales support specialist (b)(6), on 12/09/2019) notification of a two-step spade implant removal to occur at (b)(6) hospital due to patient noncompliance and resulting infection.No date was provided for the intended removal procedure.A list of questions was provided to the reporter to obtain additional information.Contact was made with (b)(6), (b)(6) hospital's director of quality, risk management, women's center, and sleep disorder, was made on (b)(6) 2019 via phone call.After speaking with (b)(6), she agreed to send over the needed information and was again provided the list of questions.As of 01/06/2020, a response has not been received yet from (b)(6).Additional contact has been made, and (b)(6) has stated that information should be able to be provided by 01/10/2020.An mdr is being submitted in accordance with internal procedure sop qlt-006, fda medical device reporting rev 012 and additional details shall be provided in a follow up submission, as necessary.
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Event Description
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Initial submission: on 12/06/2019, a trilliant sales representative emailed in (email received by a sales support specialist on 12/09/2019) notification of a two-step spade implant removal to occur due to patient noncompliance and resulting infection.No date was provided for the intended removal procedure.A list of questions was provided to the reporter to obtain additional information.Contact was made with the facility's director of quality, risk management, women's center, and sleep disorder on (b)(6) 2019 via phone call.After speaking with the facility representative, she agreed to send over the needed information and was again provided the list of questions.As of 01/06/2020, a response has not been received yet from the facility representative.Additional contact has been made, and the facility representative has stated that information should be able to be provided by 01/10/2020.An mdr is being submitted in accordance with internal procedure sop qlt-006, fda medical device reporting rev 012 and additional details shall be provided in a follow up submission, as necessary.Follow-up submission: the following information was provided by the original facility representative along with another facility representative regarding the 204-30-028 (3.4x3.0x28mm hammertoe implant) removal that occurred on (b)(6) 2019.Possible lot numbers for the removed 204-30-028 would be tsl002279 (qty of 2 within the trilliant sales representative's inventory at the time of implantation) and tsl004643 (qty of 1 within the trilliant sales representative's inventory at the time of implantation).Questions regarding the original implantation procedure: date of the original implantation case, facility and performing surgeon: on (b)(6) 2019, [facility], dr.[doctor].Gender and age of the patient: male, 43 yo.Are x-rays available? yes.Questions regarding the removal procedure: date of the implant removal case at [facility]: on (b)(6) 2019.Doctor's name who performed the removal: dr.[doctor].What size implant was implanted/removed? 3.4x3.0x28mm implanted & removed.Are x-rays available? yes.Was the implant disposed of after removal or retained by the facility? sent to pathology for gross only.
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Manufacturer Narrative
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Notes to form 3500a and justification for information not provided (in initial or follow-up submission) as required per 21cfr803.52 is below.Trilliant surgical attempted to obtain the omitted information (items 1-9 below) as part of internal complaint handling activities.1.Patient date of birth (a2) and weight (a4) not reported.2.Catalog# and serial# (d4) not utilized by trilliant surgical.3.Expiration date (d4) not applicable (n/a) to non-sterile trilliant surgical products.4.Lot# and unique identifier (udi)# (d4) could not be confirmed.All possibilities are listed below.5.Reprocessor name and address (d9) n/a to this report.6.Concomitant medical products and therapy dates (d11) not reported.7.As a result of item 4 above, device manufacture date (h4) could not be confirmed.All possibilities are listed below.8.Section h9 n/a to this report.9.No files attached to this report.Corrected information provided in follow-up submission: b3: date of event left blank because unknown.B5: description of event/problem for initial submission corrected to not identify any physician or institution by name.D2: common device name (product code is correct in initial submission).D4: catalog#, serial#.D5: operator of device corrected to patient/lay user as the event is considered to be an infection.This infection is a result of patient noncompliance.The operator of the device when the event occurred was the patient.Section f is n/a to this report.H6 - patient code, device code, and method codes (result code and conclusion code are correct in initial submission).Additional information provided in follow-up submission: a2: age at time of event.B5: description of event/problem for follow-up submission.D4 - model#, lot#.G1: name (and email address) updated as different personnel than submitted the initial submission is submitting the follow-up submission.Additional investigation performed upon receiving additional information: it was concluded that the implant was sent to pathology and will not be returned to corporate.As it was determined on 01/21/2020, the potential lot numbers for the removed 3.4mm x 3.0mm x 28mm hammer toe implant include the following: 1.Tsl002279 [manufactured 05/21/2015, udi: (b)(4)] the device history record (dhr) for lot# tsl002279 was reviewed and confirmed to have no significant events (i.E.Reworks (rwks), nonconformances (ncrs), deviations).2.Tsl004643 [manufactured 02/24/2017, udi: (b)(4)] the dhr for lot#: tsl004643 was reviewed.Ncr 17-033 identified all parts failing for the anodization being insufficient and inconsistent.Rwk 17-011 was initiated to correct the anodization error.All parts were inspected and accepted following rwk 17-011.Deviation 16-0010 was applied to the lot to add a functional verification of the part in accordance with ifu 900-01-008 rev j.No issues identified in the dhr review are related to the reported complaint.
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Search Alerts/Recalls
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