MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE 3.5MM X 16MM ARSENAL LOCKING SCREW; SCREW, FIXATION, BONE

Catalog Number	308-35-016
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "10 hole lateral fib plate left (300-93-005).2nd most distal hole, anteriorly.First screw 3.5x16 locking (308-35-016) caused "curly cues" off of it and spun in the plate.A 2nd screw same size was put in, no curly cues but seated better.However didn't have a hard lock into plate.Left 2nd screw in plate." 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 "10 hole lateral fib plate left (300-93-005).2nd most distal hole, anteriorly.First screw 3.5x16 locking (308-35-016) caused "curly cues" off of it and spun in the plate.A 2nd screw same size was put in, no curly cues but seated better.However didn't have a hard lock into plate.Left 2nd screw in plate.".

• Brand Name: 3.5MM X 16MM ARSENAL LOCKING SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston, TX 77007
• Manufacturer (Section G): TRILLIANT SURGICAL, LLC D/B/A DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston, TX 77007
• Manufacturer Contact: justin lovelace ; 727 north shepherd drive; suite 100; houston,, TX 77007
• MDR Report Key: 19464346
• Report Number: 3007420745-2024-00003
• Device Sequence Number: 20688862
• Product Code: HWC
• UDI-Device Identifier: 00810028391154
• UDI-Public: 00810028391154
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: 308-35-016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 300-93-005 LOT: UNKNOWN
• Patient Age: 75 YR
• Patient Sex: Female