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

Catalog Number OM-1502

Device Problems Positioning Failure (1158); Noise, Audible (3273)

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

Event Date 08/07/2017

Event Type  malfunction  

Event Description

It was reported that when attempting to deploy the anchor, the black handle closed and a loud crack was heard but both anchors wings had not deployed.The surgeon removed sutures and re-stitched with perfect passer and same problem occurred with a 2nd anchor.The procedure was successfully completed using a helix anchor to maintain suture tension and a 3rd magnum 2 anchor which deployed as expected.Complaint 2 of 2.See (b)(4) for original report.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned for evaluation.There was a relationship found between the device and the reported incident.Visual inspection of the returned magnum2 knotless implant om-1502 shows a deployed device.The sutures are visible outside the metal rod and contaminated with bloody substances.Both sutures were completely reeled through the wheel.The wings are in a partially opened state at distal end.There are no manufacturing abnormalities visually observed with the returned instrument.The complaint was 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: (1) improper suture loading, (2) excessive tensioning or (3) improper alignment of the inserter handle with the bone hole.

Manufacturer Narrative

The reported magnum 2 was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Per customer communication the device was being returned for evaluation; however we have not received the device.Customer complaint cannot be verified due to the product was not returned.Root cause is unable to be determined; however the most probable cause may be due to: improper alignment of the implant and inserter handle with the bone hole while inserting the implant.Bending or twisting of the inserter handle during and after insertion will damage the implant or incomplete insertion may result.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; austin, TX 78735
• MDR Report Key: 6833420
• MDR Text Key: 85626501
• Report Number: 3006524618-2017-00243
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• 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: 1154341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR