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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
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 after an initial implantation in (b)(6) 2020 the plate was found to be broken.Therefore a revision surgery was performed on (b)(6) 2020 and the broken plate was replaced with a new one with the same part number.It was further reported that the breakage point of the plate was not at the breakage point of the bone.The patient initially did not realized that the plate was broken.
Additional Manufacturer Narrative
Complaint confirmed, the plate broke at the 2nd oblong hole.Relevant features were measured and found to meet specifications.Review of the material certificate also confirms the device met material specifications.The cause of the event is undetermined.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11981848
• Report Number: 1220246-2021-03246
• Device Sequence Number: 11051030
• Product Code: HRS
• UDI-Device Identifier: 00888867027442
• UDI-Public: 00888867027442
• 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: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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-2653CL
• Device Lot Number: 5261918
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 09/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other