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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/21/2021

Event Type  Injury  

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 Description

It was reported that 6-8 weeks after the initial implantation the device loosened.A revision surgery had to be performed on the (b)(6) 2021.During the revision surgery the device was removed and the revision surgery was finished successfully with a longer clavicula plate.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Type of Device: PLATE, FIXATION, BONE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12196605
• MDR Text Key: 262505060
• Report Number: 1220246-2021-03405
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867027404
• UDI-Public: 00888867027404
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2021

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
• Device Operator: Health Professional
• Device Model Number: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Device Catalogue Number: AR-2651CL
• Device Lot Number: 5281951
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other