MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/B/A DJO FOOT AND ANKLE 2.7MM X 18MM ARSENAL LOCKING SCREW; SCREW, FIXATION, BONE

Catalog Number	308-27-018
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that while inserting 2.7x18mm locking screw into the "new" mpj petite r 0 degree plate in the compression slot and curly cue came off of the screw.Reported added that "curly cue" punctured the glove and skin of the surgeon.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 2.7x18mm locking screw into the "new" mpj petite r 0 degree plate in the compression slot and curly cue came off of the screw.Reported added that "curly cue" punctured the glove and skin of the surgeon.
Additional Manufacturer Narrative
There were three similar complaints identified for arsenal locking screws creating burrs.However, the similar complaints are regarding 3.5mm locking screws and the locking hole on the plates, while this event is regarding a 2.7mm locking screw and the compression hole.Thus, the similar complaints do not aid in root cause analysis.There were no abnormalities in regards to dhr review for the plate.Dhr review did not occur for the locking screw as there were 17 potential lots identified.Visual inspection and dimensional inspection did not occur.Simulated use testing occurred and confirmed the formation of a burr when not utilizing the drill guide.The surgical technique was not adhered to as the drill guide was not utilized while drilling the compression hole.The surgeon stated the locking screw was drilled in the center of the compression hole to "not influence the position of the plate" after all other locking holes were filled.The arsenal std 2.7-3.5mm compression screw hole is designed with a ramp which directs the screw to achieve compression.However, as the surgeon was attempting to not influence the position of the plate and did not desire compression, the screw was inserted in the middle of the compression hole.This method of insertion likely resulted in two points of contact between the screw and plate, resulting in possible damage to either the screw or plate.However, as no images, x-rays, or product was returned for this event, potential damage to the screw or plate could not be confirmed.As the drill guide was not utilized, the root cause shall be attributed to user error.

• Brand Name: 2.7MM 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 ; 4847879764
• MDR Report Key: 19464343
• Report Number: 3007420745-2024-00002
• Device Sequence Number: 12618318
• Product Code: HWC
• UDI-Device Identifier: 00810028390997
• UDI-Public: 00810028390997
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: D356720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 308-27-018
• Device Lot Number: TSL015952
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Female