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

Catalog Number OM-2500

Device Problems Break (1069); Material Puncture/Hole (1504)

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

Event Date 10/22/2018

Event Type  malfunction  

Event Description

It was reported that the device was used in the procedure and while there continued to turn the wheel to inserted the anchor into the hole the line at the wheel broke also the suture cut too.There was not any pieces after procedure inside the patient and a backup device was available to complete the procedure with no significant delay.

Manufacturer Narrative

The returned instrument, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the om-2500 shows a deployed device with a suture lock button in its original state.The suture lock button is not pressed down.The snare line with loop is reeled into the wheel.The snare loop is intact.The implant is not detached.No suture is available.The instrument is not damaged as reported.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 anchor could be detached by pressing down the suture lock button and by moving the lever.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.

Manufacturer Narrative

The reported minimagnum knotless implant 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 evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿device was used in the procedure and while there continued to turn the wheel to insert the anchor into the hole the line at the wheel broke also the suture cut too.¿ an exact root cause cannot be determined with confidence; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) incorrect suture used.(2) over tensioning (3) device misalignment.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.Sales representative blank and health professional marked.

Event Description

It was reported that the device was used in the procedure and while the surgeon continued to turn the wheel to inserted the anchor into the hole, the line at the wheel broke making the suture to cut too.There was no pieces after procedure inside the patient and a backup device was available to complete it with no significant delay.

• Brand Name: MINIMAGNUM KNOTLESS IMPLANT PKG
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8060234
• MDR Text Key: 127076380
• Report Number: 3006524618-2018-00585
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00817470005592
• UDI-Public: 00817470005592
• Combination Product (y/n): N
• PMA/PMN Number: K042584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2019

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: 01/31/2020
• Device Catalogue Number: OM-2500
• Device Lot Number: 1175424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 12/17/2018; 03/14/2019
• Supplement Dates FDA Received: 12/18/2018; 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1