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

Catalog Number OM-1502

Device Problem Unraveled Material (1664)

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

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) zipcode.

Event Description

It was reported that during rotator cuff repair procedure, the relay coil on anchor kept unravelling when tensioning suture.Problem resulted in an extended procedure time.No patient injuries were reported.Procedure was completed with a backup device.

Manufacturer Narrative

The returned devices, intended for use in treatment, were returned as mdr¿s for evaluation.There were a relationship found between the returned devices and the reported incident.Visual inspection of the returned magnum2 knotless implant om-1502 shows deployed devices.There are no manufacturing abnormalities visually observed with the returned instruments.The magnum2 knotless is a single used device and cannot be functional tested.An attempt was made to test the basic functions of this instrument.The complaint was not verified and the root cause could not be determined with certainty.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: improper suture loading, excessive tensioning or improper alignment of the inserter handle with the bone hole.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Report source: company representative, blank.

• 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
• MDR Report Key: 7969601
• MDR Text Key: 123971684
• Report Number: 3006524618-2018-00541
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K042914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OM-1502
• Device Lot Number: 1147508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1