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	06/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a problem with a clavicular plate.At 6 weeks after the initial surgery the plate fractured.This led to recurrent pain, bone deformation and surgical resumption.The plate was removed and a new one was put in place.No further information received.
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-2654cl serial/batch number (b)(6) was received for investigation along with seven screws.Functional testing was not performed due to the damage to the device.Upon visual inspection, it was observed that the plate is fractured into two pieces, accompanied by several nicks, scratches and dents on its surface.The thickness of both halves was measured using a point micrometer and found that the dimensions were 0.093 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 0.380 which are in tolerance of the specified 0.380 ± 0.005.The most likely cause of the reported failure is a patient-specific event.According to dfu-0192-9 at revision 0.Warnings.5.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.

• 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: 17665353
• Report Number: 1220246-2023-07751
• Device Sequence Number: 6208169
• Product Code: HRS
• UDI-Device Identifier: 00888867027466
• UDI-Public: 00888867027466
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/05/2024

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 Model Number: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Device Catalogue Number: AR-2654CL
• Device Lot Number: 13708277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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
• Patient Sex: Unknown