MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE 3.0MM X 28MM TIGER CANNULATED SCREW; TIGER CANNULATED SCREW SYSTEM SCREW, PRODUCT CODE: HWC

Model Number	200-30-028
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 1-11 below) as part of internal complaint handling activities.Patient weight: not reported.Date of event: is unknown.The event is considered to be when the patient began to experience pain.Catalog # and serial #: not utilized by trilliant surgical.Expiration date: not applicable (n/a) to non-sterile trilliant surgical products.Initial reporter fax: not provided.Device bla number: is n/a to this report.N/a was not entered within the field for bla number as this caused technical errors to occur in previous mdr submissions.Report source: n/a to this report.Follow-up: n/a to this report, as this report is an initial submission.The device(s) was not evaluated by manufacturer.The device(s) were not returned.It is to be noted that the reporter was unable to confirm which screw(s) or if all screws were removed.Thus, all four (4) screws implanted were investigated.No files attached to this report.Investigation (including evaluation summary of device(s) returned to manufacturer [if part returned]).Evaluation of similar complaints: the complaints log was reviewed to identify any similar events involving a tiger screw removal between november 2020 and november 2021.Eleven (11) similar complaints were identified.Of these eleven (11) identified complaints, the root causes were as follows: unknown (7), field other (1), patient anatomy (1), no identified defect (1), and ifu not followed (1).None of these related events can be confirmed to contain parts from the same lot number as the reported event as the lot number for the reported event is not confirmed.Device history record (dhr) review: the dhr for the following lots were reviewed to identify if any significant events occurred corresponding to the hardware involved in the event.Within lot tsl001269 [(b)(4); released 06/25/2014], no significant events reworks (rwks), nonconformances (ncrs), or deviations (dev) occurred.Within lot 75hk1901 [(b)(4); released 08/20/2011], no significant events reworks (rwks), nonconformances (ncrs), or deviations (dev) occurred.Within lot tsl001768 [(b)(4); released 10/29/2014], no significant events reworks (rwks), nonconformances (ncrs), or deviations (dev) occurred.Within lot tsl001554 [(b)(4); released 09/10/2014], no significant events reworks (rwks), nonconformances (ncrs), or deviations (dev) occurred.Review of surgical technique: tiger cannulated screw system instructions for use, ifu 900-01-002 revision p, 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.Visual inspection: the part(s) were not returned.Dimensional inspection: the part(s) were not returned.Simulated use testing: as simulated use testing is unable to recreate "pain and tenderness" after hardware was implanted for 6.5 years, simulated use testing was not performed.Investigation conclusion: similar complaints were identified.However, none provided further assistance into the evaluation of a root cause.There were no identified issues in regards to dhr review.It is unknown if the doctor / user followed the ifu as limited information was provided in regards to the implantation procedure.The part was not returned.Thus, visual inspection and dimensional inspection could not occur.Simulated use testing was not performed.As a result of the limited information available and x-rays not provided, the root cause of the patient experiencing "pain and tenderness when putting on right shoe on the 1st met hallux" remains unknown.
Event or Problem Description
On (b)(6) 2021, representative 1 from facility 1 called the djo order management team to request a removal kit for a 2.0 tiger screw removal case scheduled for (b)(6) 2021 with doctor 1 at facility 2 due to patient pain.On 12/02/2021, djo sales support manager contacted representative 1 to request further information on the removal case.Representative 1 stated that the original implantation surgery took place at facility 3 on (b)(6) 2015.Representative 1 stated the patient came to facility 2 reporting of "pain and tenderness when putting on right shoe on the 1st met hallux".
Additional Manufacturer Narrative
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 1-11 below) as part of internal complaint handling activities.Patient weight: not reported.Date of event: is unknown.The event is considered to be when the patient began to experience pain.Catalog # and serial #: not utilized by trilliant surgical.Expiration date: not applicable (n/a) to non-sterile trilliant surgical products.Initial reporter fax: not provided.Device bla number: is n/a to this report.N/a was not entered within the field for bla number as this caused technical errors to occur in previous mdr submissions.Report source: n/a to this report.Follow-up: n/a to this report, as this report is an initial submission.The device(s) was not evaluated by manufacturer.The device(s) were not returned.It is to be noted that the reporter was unable to confirm which screw(s) or if all screws were removed.Thus, all four (4) screws implanted were investigated.No files attached to this report.Investigation (including evaluation summary of device(s) returned to manufacturer [if part returned]).Evaluation of similar complaints: the complaints log was reviewed to identify any similar events involving a tiger screw removal between november 2020 and november 2021.Eleven (11) similar complaints were identified.Of these eleven (11) identified complaints, the root causes were as follows: unknown (7), field other (1), patient anatomy (1), no identified defect (1), and ifu not followed (1).None of these related events can be confirmed to contain parts from the same lot number as the reported event as the lot number for the reported event is not confirmed.Device history record (dhr) review: the dhr for the following lots were reviewed to identify if any significant events occurred corresponding to the hardware involved in the event.Within lot tsl001269 [udi (b)(4); released 06/25/2014], no significant events reworks (rwks), nonconformances (ncrs), or deviations (dev) occurred.Within lot 75hk1901 [ud i (b)(4); released 08/20/2011], no significant events reworks (rwks), nonconformances (ncrs), or deviations (dev) occurred.Within lot tsl001768 [udi (b)(4); released 10/29/2014], no significant events reworks (rwks), nonconformances (ncrs), or deviations (dev) occurred.Within lot tsl001554 [udi (b)(4); released 09/10/2014], no significant events reworks (rwks), nonconformances (ncrs), or deviations (dev) occurred.Review of surgical technique: tiger cannulated screw system instructions for use, ifu 900-01-002 revision p, 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.Visual inspection: the part(s) were not returned.Dimensional inspection: the part(s) were not returned.Simulated use testing: as simulated use testing is unable to recreate "pain and tenderness" after hardware was implanted for 6.5 years, simulated use testing was not performed.Investigation conclusion: similar complaints were identified.However, none provided further assistance into the evaluation of a root cause.There were no identified issues in regards to dhr review.It is unknown if the doctor / user followed the ifu as limited information was provided in regards to the implantation procedure.The part was not returned.Thus, visual inspection and dimensional inspection could not occur.Simulated use testing was not performed.As a result of the limited information available and x-rays not provided, the root cause of the patient experiencing "pain and tenderness when putting on right shoe on the 1st met hallux" remains unknown.
Event or Problem Description
On (b)(6) 2021, representative 1 from facility 1 called the djo order management team to request a removal kit for a 2.0 tiger screw removal case scheduled for (b)(6) 2021 with doctor 1 at facility 2 due to patient pain.On (b)(6) 2021, djo sales support manager contacted representative 1 to request further information on the removal case.Representative 1 stated that the original implantation surgery took place at facility 3 on (b)(6) 2015.Representative 1 stated the patient came to facility 2 reporting of "pain and tenderness when putting on right shoe on the 1st met hallux".

• Brand Name: 3.0MM X 28MM TIGER CANNULATED SCREW
• Common Device Name: TIGER CANNULATED SCREW SYSTEM SCREW, PRODUCT CODE: HWC
• Manufacturer (Section D): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston TX 77007 1320
• Manufacturer (Section G): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston TX 77007 1320
• Manufacturer Contact: kayla gary ; 727 north shepherd drive; suite 100; houston, TX 77007-1320 ; 8004952919
• MDR Report Key: 13099214
• Report Number: 3007420745-2021-00029
• Device Sequence Number: 2047729
• Product Code: HWC
• UDI-Device Identifier: 00812926021010
• UDI-Public: (01)00812926021010(10)TSL001269
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 200-30-028
• Device Lot Number: TSL001269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 200-24-014, 2.4MM X 14MM TIGER CANNULATED SCREW; 200-24-016, 2.4MM X 16MM TIGER CANNULATED SCREW; 200-24-018, 2.4MM X 18MM TIGER CANNULATED SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male