MAUDE Adverse Event Report: ARTHROCARE CORP. MULTIFIX S PEEK 5.5MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	OM-2300
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the device broke when the threads were going through during surgery.The surgeon changed the device to a ref (b)(4) to end the surgery.The piece remain secured inside the patient.No patient injuries were reported.
Additional Manufacturer Narrative
The device was returned for evaluation.There was a relationship found between the device and the reported incident.The visual inspection of the device shows a device that has been used.The implant at distal end is attached and not damaged.The ¿loop¿ to pull the thread through was returned broken.There were no visible manufacturing abnormalities with the returned device.The multifix s-peek 5.5mm is a single used device and could not be functional tested.The deployment knob and the end cap could be rotate easily.No damages or manufacturing abnormalities could be identified on the dial.The complaint was verified, but a root cause could not be determined with certainty.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) bend or twist the inserter handle during or after insertion, (2) excessive forces during insertion (3) improper alignment of the inserter handle with the bone hole.The instructions 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.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: MULTIFIX S PEEK 5.5MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7167255
• Report Number: 3006524618-2018-00010
• Device Sequence Number: 10996156
• Product Code: MBI
• UDI-Device Identifier: 00817470000580
• UDI-Public: (01)00817470000580(17)200630(10)2005171
• Combination Product (Y/N): N
• PMA/510(K) Number: K140604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: OM-2300
• Device Catalogue Number: OM-2300
• Device Lot Number: 2005171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1