MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS SUTURE PASSER; ACCESSORIES,ARTHROSCOPIC

Catalog Number 22-4035

Device Problem Mechanical Problem (1384)

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

Event Date 01/27/2017

Event Type  malfunction  

Event Description

It was reported that firstpass needle passed the suture through the tendon but not enough for the capture mechanism to grab it.The surgeon made multiple attempts with the same result.The trap had to be removed and the suture grasped manually with an instrument to completely pass it through the tendon.The incident resulted in a surgical delay of approximately one hour.No patient injury or other complications were reported.

Manufacturer Narrative

The reported firstpass device was not returned for evaluation.A relationship between the device and reported incident cannot be established as the product was not returned for investigation.Without the reported device, a visual evaluation cannot be performed.From the information provided, the needle passed the suture through the tendon but not enough for the capture mechanism to grab it.Due to product not being available for evaluation the complaint could not be verified.An exact root cause cannot be determined; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: improper alignment between needle eyelet and jaw slot.Inadequate needle over-travel distance.Improper handle function or needle interface.Or wrong suture used with device.The instruction for use (ifu) were reviewed and were 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 during manufacturing record review that would suggest the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

Visual inspection of the returned device shows no visual discrepancies.Functional test was performed on the returned device using white magnumwire suture, a demo needle and suture trap, both known to be in acceptable working condition.Foam was also used to replicate the tissue.The needle was able to penetrate thru the foam and pass a stitch.Functional test was achieved successfully.From the information provided, the needle passed the suture through the tendon but not enough for the capture mechanism to grab it.Based on our visual and functional inspection, customers¿ complaint was not confirmed as the device performed within its expected parameters and no visual discrepancies were observed.Customers complaint was not confirmed.The instruction for use (ifu) were reviewed and were 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.

• Brand Name: FIRSTPASS SUTURE PASSER
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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 ; 5123585706
• MDR Report Key: 6298556
• MDR Text Key: 66683696
• Report Number: 3006524618-2017-00037
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2017

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 Catalogue Number: 22-4035
• Device Lot Number: 29438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/09/2017; 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1