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	11/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the item broke due to hard bone, it broke by the bicipital groove.No patient injuries were reported.
Additional Manufacturer Narrative
The reported multifix s device, intended for use in treatment, was returned for evaluation.A relationship between the device and reported incident was established.From the information provided, the item broke due to hard bone.Visual inspection shows the die was received broken near the threads.Distal end of the die threads was left inside the body anchor.The anchor body was also found with its tip blunt.Root cause based on information provided and visual observations may be due to the bone condition.Hard bone condition can result in damage to the device.

• 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: 7085203
• Report Number: 3006524618-2017-00392
• Device Sequence Number: 1351651
• Product Code: MBI
• UDI-Device Identifier: 00817470000580
• UDI-Public: (01)00817470000580(17)181231(10)1130119
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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 Model Number: OM-2300
• Device Catalogue Number: OM-2300
• Device Lot Number: 1130119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1