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

Model 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

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.Rotating the suture ratchet knob performed as intended.Pressing down the lock button with a single squeeze of the black hand-lever activates the bone lock and detaches the implant as specified.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.

• 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: 7969600
• MDR Text Key: 123971845
• Report Number: 3006524618-2018-00544
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00817470005486
• UDI-Public: (01)00817470005486(17)210118(10)2009178
• 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 Expiration Date: 01/18/2021
• Device Model Number: OM-1502
• Device Catalogue Number: OM-1502
• Device Lot Number: 2009178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1