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

Model Number 72290001

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that, 6 days after a shoulder procedure, the patient may be having an allergic reaction to a multifix device.The patient's outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h2, h6.The reported device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a isolated issue.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found proper preoperative and operating procedures instructions statements.Clinical evaluation was completed and concluded that no relevant clinical information has been provided to confirm the reported reaction to the multifix device, therefore, a thorough medical investigation cannot be rendered.Since it was reported the patient¿s outcome is unknown, no further clinical/medical investigation is warranted at this time.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Factors that could have contributed to the reported event include: (1) potential complications accompanying such implant surgery.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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: 10825213
• MDR Text Key: 215888244
• Report Number: 3006524618-2020-00982
• 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
• Report Date: 12/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 72290001
• Device Catalogue Number: 72290001
• Device Lot Number: 2053254
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other