MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS; WASHER, BOLT, NUT

Model Number	CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that a clavicle fracture plate broke post operative 6 weeks after the implantation on (b)(6) 2023.The patient further reported that no trauma has occurred.A revision surgery was performed on the (b)(6) 2023.*** 15-sep-2023 update dw.Further information were provided that the event is related to an ar-2652cl with the lot: 5262127.
Additional Manufacturer Narrative
Complaint is confirmed.Functional testing was not performed on the returned ar-2652cl due to the damage to the device.Visual evaluation noted that the plate is broken in half.The thickness of both halves was measured using a point micrometer and found that the dimensions were 0.090 and 0.092 which are in tolerance of the specified 0.090 ± 0.005.The width of both halves were measured using a caliper and found that the dimensions were 0.380 and 0.381 which are in tolerance of the specified 0.380 ± 0.005.The most likely cause for the reported failure can be attributed to a patient-specific event.Refer to the investigation photos.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Common Device Name: WASHER, BOLT, NUT
• 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: emily shafer ; 8009337001
• MDR Report Key: 17877339
• Report Number: 1220246-2023-08069
• Device Sequence Number: 7182733
• Product Code: HRS
• UDI-Device Identifier: 00888867027428
• UDI-Public: 00888867027428
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 11/12/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Device Catalogue Number: AR-2652CL
• Device Lot Number: 5262127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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