MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/B/A DJO FOOT AND ANKLE 3.5MM X 18MM ARSENAL LOCKING SCREW; SCREW, FIXATION, BONE

Catalog Number	308-35-018
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that while inserting a 3.5x18mm locking screw into the new petite mpj 0degree left plate it caused a curly cue while locking in the compression slot.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
It was reported that while inserting a 3.5x18mm locking screw into the new petite mpj 0degree left plate it caused a curly cue while locking in the compression slot.
Additional Manufacturer Narrative
It was reported that while inserting a 3.5x18mm locking screw into the new petite mpj 0degree left plate it caused a curly cue while locking in the compression slot.There were three similar complaints identified for arsenal locking screw burrs.All similar complaints were reported by the same reporter as this event.Two of the similar complaints are regarding 3.5mm screws and the plate locking hole.As this complaint is regarding a 3.5mm screw and a compression hole, the similar complaints do not aid in root cause determination.One similar complaint is regarding a 2.7mm screw and a compression hole.The root cause determined user error contributed to the event.As the surgical technique remains unknown for this event, it can not be attributed to error.There were 51 potential lot numbers identified for 308-35-018.As there are more than 10 unique lot numbers , the lot numbers are less definite and significant to aiding in the complaint investigation for the device in the reported event.Thus, dhr review did not occur.There were no details provided regarding the surgical technique.Previously investigated complaint determined incorrect surgical technique contributed to the creation of a burr.However, this can not be confirmed for this reported event.As the conditions regarding the event remain unknown, simulated use testing would not further aid in root cause determination.The order of screw insertion remains unknown and the use of a drill guide could not be confirmed.Simulated use testing conducted in similar complaint confirmed damage to the plate when the compression hole is utilized after all locking holes are filled.Representative image of burr created in compression the risk is low with a risk index level of 1.A severity level of 1 (negligible) is appropriate as the burr did not cause injury or impairment to the surgeon.It was determined that 115 arsenal reloaded plates were sold between march 2024 and may 2024.With 1 reported event of a 3.5 locking screw creating a burr in the compression hole, the calculated occurrence rate is 0.869%.Though the calculated occurrence falls within a level 4 (occasional), a level 3 (seldom) shall remain appropriate at this time as this is the first reported occurrence regarding a 3.5mm screw.There were three similar complaints identified for arsenal locking screws creating burrs.Two of the identified similar complaints were regarding a locking hole and do not aid in root cause determination as this event is regarding the compression hole.One similar complaint, was initiated by the same reporter for a burr generated from a 2.7mm locking screw and compression hole.Although this event is regarding a 3.5mm screw, both complaints are regarding similar plate designs (300-82-014,petite mtp plate, r, 0°, and 300-82-013, petite mtp plate, l, 0°).The previously conducted complaint confirmed incorrect surgical technique was utilized resulting in a burr.As both events occurred within two weeks of each other, there is potential for a similar technique to be utilized in this event.However, limited information was provided regarding the procedure, so surgical technique could not be confirmed.The plate construct remains implanted, so visual and dimensional inspection did not occur.Simulated use testing did not occur due to limited information provided regarding the procedure.The reporter provided an x-ray confirming the locking screw is located at the bottom of the compression hole ramp due to the limited information provided regarding the procedure, the root cause shall remain unknown.

• Brand Name: 3.5MM X 18MM ARSENAL LOCKING SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): TRILLIANT SURGICAL, LLCD/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston TX 77007
• Manufacturer (Section G): TRILLIANT SURGICAL, LLCD/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston TX 77007
• Manufacturer Contact: stacey bonnell ; 727 north shepherd drive; suite 100; houston, TX 77007
• MDR Report Key: 19581359
• Report Number: 3007420745-2024-00004
• Device Sequence Number: 7326301
• Product Code: HWC
• UDI-Device Identifier: 00810028391161
• UDI-Public: 00810028391161
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D356720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 308-35-018
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown