MAUDE Adverse Event Report: ARTHROCARE CORP. MAGNUM M; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number OM-1525

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 09/12/2016

Event Type  Injury  

Event Description

It was reported that approximately three weeks after the surgery, the patient had to have his shoulder cleaned out as there was an infection.The cultures came back for the patient and it was determined that the infection was due to bacteria called propionibacterium acnes; the surgeon stated it most likely came from acne that the patient had.

Manufacturer Narrative

The reported magnum m device was not returned for evaluation and was intended for treatment.A relationship between the device and reported incident cannot be established as the product was not returned for investigation.Visual inspection and functional evaluation of the product could not be performed because the device was not available for investigation.From the information provided, the patient developed an infection possibly due to acne that the patient had therefore patient had to have his shoulder cleaned out.Due to product not being available for return, the complaint could not be verified and exact root cause for the failure is uncertain.However, factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: preoperative patient condition.As stated by the complainant, the infection may have been due to the patient¿s pre-existing condition.The instruction for use (ifu) outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: MAGNUM M
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: james gonzales ; 7000 w. william cannon dr.; austin, TX 78735 ; 5123585706
• MDR Report Key: 6028770
• MDR Text Key: 57398950
• Report Number: 3006524618-2016-00275
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

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 Catalogue Number: OM-1525
• Device Lot Number: 1061993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other