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

Catalog Number OM-1502

Device Problems Device Slipped (1584); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during surgery, the spring failed and popped out in anchor deployment.Sutures were unable to be tensioned; therefore, the faulty anchors remain stuck in patient.A further anchor of same lot was attempted and same failure repeated.Additional bone holes were required to insert the other anchors.The procedure was successfully completed with use of same anchor, but from different lot number without a considerable delay.No patient injury or other complications were reported.

Manufacturer Narrative

C-0241370 the returned devices, intended for use in treatment, were returned an mdr¿s for evaluation.There was no relationship found between the returned devices and the reported incident.Visual inspection of the returned magnum2 knotless implant om-1502 shows deployed instrument.The implants at distal end were detached on both instruments and not returned with the devices.There are no manufacturing abnormalities visually observed with the returned instruments.The magnum2 is a single use device and could not be functional tested.The complaint was not verified and the root cause could not be determined with certainty.The instruments were damaged with missing parts and on device #1 missing screws.This instrument was opened.All missing parts were not returned with the devices.Factors unrelated to the manufacture or design of the devices that could have contributed to the reported event includes: (1) improper suture loading, (2) excessive tensioning/forces or (3) improper alignment of the inserter handle with the bone hole.The instructions for use was reviewed and 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.C-00241000 the returned devices, intended for use in treatment, were returned as an mdr¿s for evaluation.There was no relationship found between the returned devices and the reported incident.The complaint was not verified, but the root cause could not be determined with certainty as the products are in its original state and there were no indications during manufacturing record review that would suggest that the devices 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: 8518639
• MDR Text Key: 142332763
• Report Number: 3006524618-2019-00188
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00817470005486
• UDI-Public: 00817470005486
• Combination Product (y/n): N
• PMA/PMN Number: K042914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: OM-1502
• Device Lot Number: 2024262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1