MAUDE Adverse Event Report: ARTHROCARE CORP. MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72290001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Erythema (1840); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 12/17/2018

Event Type  Injury  

Event Description

It was reported that 6-7 weeks after shoulder surgery performed on (b)(6) 2018 using a regeneten patch, the patient went to physical therapy and the therapist noted the shoulder was very red and swollen.The physician aspirated a large amount of pus from the patient's shoulder.Subsequently on (b)(6) 2018, an incision and drainage wash out that included removal of the patch and remaining suture material was performed due to suspected infection and/or implant rejection.It was stated that the previously implanted s&n suture anchors remained in the patient and test results were negative for infection.Current patient status is unknown, however, no further complications have been reported.

Event Description

It was reported that 6-7 weeks after shoulder surgery performed on (b)(6) 2018 using a regeneten patch, the patient went to physical therapy and the therapist noted the shoulder was very red and swollen.The physician aspirated a large amount of pus from the patients shoulder.Subsequently on (b)(6) 2018, an incision and drainage wash out that included removal of the patch and remaining suture material was performed due to suspected infection and/or implant rejection.It was stated that the previously implanted s&n suture anchors remained in the patient and test results were negative for infection.Current patient status is a full passive range of motion but limited active range of motion, allowed to gradually resume activity as tolerated, with no trauma during her recovery.

Manufacturer Narrative

The reported mulltifix s-ultra 5.5mm knotless anchor device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿therapist noted the shoulder was very red and swollen.The physician aspirated a large amount of pus from the patients shoulder and test results were negative for infection.¿ an exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) risks and complications associated with the surgical procedure and use of the device.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.The instruction for use states: -preoperative and operative procedures, including proper patient selection, knowledge of surgical techniques, and proper device selection are important considerations when using this medical device.- the surgeon should advise the patient of the known risks and complications associated with the surgical procedure and use of this device.-the device is provided sterile for single use only.The device is only sterile if the packaging is not opened, damaged or broken.- do not resterilize or reuse the device as this may result in product malfunction, failure or patient injury, and may also expose the patient to the risk of infectious diseases.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8284621
• MDR Text Key: 134325079
• Report Number: 3006524618-2019-00035
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556614204
• UDI-Public: 00885556614204
• Combination Product (y/n): N
• PMA/PMN Number: K153669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72290001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR