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 Information (3190)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient had revision surgery for loose anchor in the sub acromial space.Only the screw part of the anchor was loose, the tip was still in place and could not be retrieved.The screw was retrieved and discarded.A revision rcr was performed on the anterior portion of the supra spinatus using a 6.5mm multifix-s ultra.
Additional Manufacturer Narrative
The reported multifix s peek 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 evaluation cannot be performed and customers complaint cannot be confirmed.
Additional Manufacturer Narrative
The reported multifix s peek 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 evaluation cannot be performed and customers complaint cannot be confirmed.

• 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: 7571504
• Report Number: 3006524618-2018-00299
• Device Sequence Number: 2018594
• Product Code: MBI
• UDI-Device Identifier: 00817470000580
• UDI-Public: (01)00817470000580(17)190430(10)1147494
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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: No Information
• Device Expiration Date: 04/30/2019
• Device Model Number: OM-2300
• Device Catalogue Number: OM-2300
• Device Lot Number: 1147494
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1