MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,RT,SS, STRL; BONE FIXATION PLATE

Model Number	CLAV FRAC PLT,CENTRAL THIRD,RT,SS, STRL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that five weeks after surgery the patient felt a cracking in his collarbone.There was a plate fracture in the 5th gliding hole of the medial clavicle plate.***update (b)(4): in addition, the plate remains in the patient for the time being.He doesn't want an operation.Regarding disabilities: his collarbone fracture has not healed.As a result, he has pain, but no more pain than before.
Event or Problem Description
Update swit (b)(6) 2024: further information was provided that during a revision surgery on (b)(6) 2024 the plate was removed out of patient and was replaced by a new plate made of titanium from another manufacturer.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,RT,SS, STRL
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19807277
• Report Number: 1220246-2024-06859
• Device Sequence Number: 20919916
• Product Code: HRS
• UDI-Device Identifier: 00888867195875
• UDI-Public: 00888867195875
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2025

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 Model Number: CLAV FRAC PLT,CENTRAL THIRD,RT,SS, STRL
• Device Catalogue Number: AR-2653CRS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 10/17/2025
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/23/2024; 10/20/2025
• 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
• Patient Sex: Unknown