MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/B/A DJO FOOT AND ANKLE SABILIZATION; 2.2MM X 16MM ARSENAL SCREW

Catalog Number	307-22-016
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A previous report was filed previous report number: 3007593722-2024-00011 this report is to update to correct manufacturer and report number.It was reported that the 2.2x16 non locking screw head broke while tightening into a 5 hole mini plate, piece left in patient.There was one similar complaint identified for an arsenal screw breaking during insertion, with an unknown root cause.There were no abnormalities identified during dhr review.The provided image confirmed the complaint and showed that the screw had broken near the head.Because one portion of the screw was discarded and the other remains in the patient, further inspection could not be performed.The complaint could not be replicated through simulated use testing.It is likely that the screw broke once most of it was implanted because the distal end of the screw could not be retrieved, and the breakage location is towards the proximal end.The breakage could have been the result of inadequate pre-drilling, which would have caused the screw to experience higher levels of torque.This cannot be confirmed with the limited surgical technique information provided.The root cause shall therefore remain unknown.
Event or Problem Description
It was reported that the 2.2x16 non locking screw head broke while tightening into a 5 hole mini plate, piece left in patient.

• Brand Name: SABILIZATION
• Common Device Name: 2.2MM X 16MM ARSENAL SCREW
• 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: 20691777
• Report Number: 3007420745-2024-00005
• Device Sequence Number: 12583237
• Product Code: HWC
• UDI-Device Identifier: 00810028390348
• UDI-Public: 00810028390348
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: D356720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/14/2024

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: 307-22-016
• Device Lot Number: 05876
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/14/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown