MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE 9MM DISCO SUBTALAR IMPLANT; SUBTALAR SYSTEM DISCO IMPLANT

Model Number 102-20-009

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 1-10 below) as part of internal complaint handling activities.Patient dob not reported.Catalog # and serial # not utilized by trilliant surgical.Date of event is unknown.The event is considered to be when the patient experienced the improperly aligned implant.Expiration date not applicable to non-sterile trilliant surgical products.Lot # and udi # could not be confirmed.All lot possibilities are listed below.Investigation; evaluation of similar complaints; the complaints log was reviewed to identify any similar events involving a subtalar removal between october 2021 and october 2022.No similar complaints were identified.Device history record (dhr) review; dhrs were reviewed to identify if any significant events occurred corresponding to the hardware involved in the event: within lot 24054-03 udi #: (b)(4), no significant events [reworks (rwks), nonconformances (ncrs), or deviations (dev)] occurred.Within lot 10669-05 udi #: (b)(4), no significant events [reworks (rwks), nonconformances (ncrs), or deviations (dev)] occurred.Review of surgical technique; disco subtalar implant system instructions for use, ifu 900-01-005 revision o, 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 parts were not returned.Thus, visual inspection did not occur.Dimensional inspection; the parts were not returned.Thus, dimensional inspection did not occur.Simulated use testing; as the part was not returned and limited information is available, simulated use testing did not occur.-investigation conclusion there are no similar complaints for a subtalar removal within the specified timeframe (october 2021 - october 2022).There are no abnormalities in regards to dhr review.It is unknown if the doctor followed the ifu as limited information was provided regarding the implantation case.It is to be noted that the explant surgery was deemed necessary based on the "improperly aligned arthroereisis implant within the subtalar joint".As the part was not returned, visual and dimensional inspection could not occur.Simulated use testing did not occur.Based on the limited information available at this time, the root cause remains unknown.

Event Description

On (b)(6) 2022, surgical services director e-mailed regional account coordinator to inquire about removal instruments regarding an upcoming 9mm disco subtalar implant (102-20-009) removal case on (b)(6) 2022 with doctor 1 on a 56 year old female patient at location 1.In a follow up email correspondence with surgical services director, he stated the 102-20-009 explant surgery is being performed due to "improperly aligned arthroereisis implant (102-20-009) within the subtalar joint." he noted that the implant surgery of the 102-20-009 was performed on (b)(6) 2015 with doctor 2 at location 2.

• Brand Name: 9MM DISCO SUBTALAR IMPLANT
• Type of Device: SUBTALAR SYSTEM DISCO IMPLANT
• 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 77007 1320
• Manufacturer Contact: kayla gary ; 727 north shepherd drive; suite 100; houston, TX 77007-1320 ; 8004952919
• MDR Report Key: 15820813
• MDR Text Key: 303915600
• Report Number: 3007420745-2022-00007
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102-20-009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 88 KG