MAUDE Adverse Event Report: ARTHROCARE CORP. DOUBLE FIX KNOTLESS PK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72290143
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implanted anchor came out from the site.A surgical delay of 2 hours to remove the anchor was reported.
Additional Manufacturer Narrative
There was a relationship found between the returned device and the reported incident.Visual inspection of the instrument show no manufacturing abnormalities.The implant was completely detached and the device was returned with the not damaged implant attached in a separate plastic bag.No sutures returned with the instrument.The parts returned show no manufacturing abnormalities.The returned double fix knotless pk is a single used device and cannot be functional tested.The complaint was verified and the root cause could not be determined with certainty.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The initial incident report was submitted with incorrect manufacturing site registration number (b)(4).The correct manufacturing site registration number is (b)(4).Corrected data: g1 contact information.

• Brand Name: DOUBLE FIX KNOTLESS PK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8151128
• Report Number: 1219602-2018-01718
• Device Sequence Number: 19255794
• Product Code: MBI
• UDI-Device Identifier: 00885556722497
• UDI-Public: 00885556722497
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2020

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: 09/10/2021
• Device Model Number: 72290143
• Device Catalogue Number: 72290143
• Device Lot Number: 2021018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 04/25/2019; 02/08/2020
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 04/26/2019; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR