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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
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 during a collarbone / clavicle surgery there was a material fracture and the clavicle plate broke during surgery.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (plate from another manufacturer).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information.Complaint allegation is confirmed.One unpackaged ar-2655cl clavicle fracture plate, central third, left batch number: 5262149 was received for investigation.Visual evaluation of the returned device noted the plate was broken.Further visual evaluation noted deep nicks to the surface of the device.Functional testing was not performed due to the damage to the device.Dimensional testing found that the thickness of the returned ar-2655cl clavicle fracture plate was 0.089 which is in tolerance of the critical dimension specified in drawing c12917 of.090±.005.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.Refer to investigation photos.
Additional Manufacturer Narrative
Additional information: b1, b2, b5, g3, h1, h6.
Event or Problem Description
Update (b)(6) 09-apr-2025: further information was requested from the customer, to confirm a plate breakage during the surgery and a new contact from the or management provided different information than the previous contact.According to the or management the clavicle plate did not break during the surgery, but the breakage of the plate occurred after the surgery and after the patient was discharged.A revision surgery was required.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• 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: 20224862
• Report Number: 1220246-2024-07647
• Device Sequence Number: 7315062
• Product Code: HRS
• UDI-Device Identifier: 00888867027480
• UDI-Public: 00888867027480
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2025

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 Model Number: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Device Catalogue Number: AR-2655CL
• Device Lot Number: 15190357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 02/20/2025; 04/09/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 03/07/2025; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2024
• 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