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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,RT,SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-2653cr clavicle fracture plate broke.This was discovered during a procedure.Additional information received on (b)(6) 2023: this was discovered during a clavicle fracture procedure.The sales representative is unsure of the surgery date.The plate was removed, and a product from another manufacturer was used to complete the case.
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.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-2653cr serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to the damage to the device.Visual inspection noted that the plate is broken in half; scratches were observed on the surface.The thickness of both halves was measured using a point micrometer and found that the dimensions were 0.091 and 0.091 which are in tolerance of the specified 0.090 ± 0.005.The width of both halves was measured using a caliper and found that the dimensions were 0.382 and 0.381 which are in tolerance of the specified 0.380 ± 0.005.The most likely cause is a user error, improper bone prep, or misaligned insertion.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,RT,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: 17597573
• Report Number: 1220246-2023-07592
• Device Sequence Number: 20687982
• Product Code: HRS
• UDI-Device Identifier: 00888867027459
• UDI-Public: 00888867027459
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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 Model Number: CLAV FRAC PLT,CENTRAL THIRD,RT,SS
• Device Catalogue Number: AR-2653CR
• Device Lot Number: 6791345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2013
• 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