MAUDE Adverse Event Report: ARTHROCARE CORP. MAGNUM 2 KNOTLESS IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number OM-1502

Device Problems Device Slipped (1584); Sticking (1597); Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2017

Event Type  malfunction  

Event Description

It was reported that the suture was placed in the tendon with the perfect passer connector.Dr.Punched a hole in the humerus to place the anchor.The suture was pulled into the anchor as per ifu.The anchor was deployed and the suture reel worked with the first two turns, however it got stuck and did not reel the suture in all the way.The tendon was therefore still loose.There was no obstruction for the anchor not to reel in the tendon.To finish the operation, the suture was cut.There was no more space to place another anchor as this was a redo.No patient injuries were reported.

Manufacturer Narrative

The reported magnum 2 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 and functional evaluation cannot be performed and customers complaint cannot be confirmed.From the information provided, the suture was snared as per ifu, anchor was deployed and reel became stuck therefore tendon was loose.An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: premature implant deployment.Premature implant deployment, prior to setting desired tension, will prevent the knobs from turning and result in loose tension between bone and tendon.Per ifu, desired tension should be set prior to deploying the implant.The instruction for use (ifu) were reviewed and were 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: MAGNUM 2 KNOTLESS IMPLANT
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 7086753
• MDR Text Key: 94394934
• Report Number: 3006524618-2017-00393
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00817470005486
• UDI-Public: (01)00817470005486(17)191031(10)1170937
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K042914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: OM-1502
• Device Catalogue Number: OM-1502
• Device Lot Number: 1170937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1