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	Serious Injury
Event or Problem Description
It was reported that post primary arcr procedure, it was noticed that tip of inserter broke and remains in the anchor by x-ray.Also, the implanted anchor came out from the site.Revision surgery was performed immediately at same day to remove the anchor, and rotator cuff was fixed with a backup device, a healicoil.
Additional Manufacturer Narrative
(b)(6).The returned instrument, intended for use in treatment, was returned as an mdr for evaluation.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.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are outlined in the precautionary states in the instruction for use such as (1) if the pound-in tip does not penetrate the bone on the first strike, create a bone hole according to step 3.Use a new anchor in the bone hole and (2) do not bend or twist the inserter handle during and after insertion as damage to the implant or incomplete insertion may result.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.It was reported that no patient harm or injury was sustained as a result of this device related incident.Aside from a surgical delay due to the revision to remove the anchor, the procedure was completed with a healicoil device.
Additional Manufacturer Narrative
H10/h11: the initial incident report was submitted with incorrect manufacturing site information and registration number (b)(4)(s+n mansfield).The correct manufacturing site information and registration number is (b)(4) (s+n austin).Corrected data: d3 and g1 manufacturing site name, address and 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: 8133527
• Report Number: 1219602-2018-01661
• Device Sequence Number: 1556928
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2020

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
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 01/07/2019; 02/15/2019; 02/15/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/08/2019; 02/19/2019; 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR