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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2021
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
The following was found during a maude review: it was reported that a patient had a midshaft clavicle that was treated with an arthrex clavicle plate on (b)(6) 2021.Reduction was an anatomic with no concerns leaving the operating room.Patient returned on (b)(6) 2021 for follow up and the hardware had failed and screws were free floating.The patient is very healthy and compliant.On (b)(6)2021 the plate was removed and replaced with a synthes clavicle plate.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12300586
• Report Number: 1220246-2021-03498
• Device Sequence Number: 19624217
• Product Code: HRS
• UDI-Device Identifier: 00888867027442
• UDI-Public: 00888867027442
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Device Catalogue Number: AR-2653CL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other