MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF; PASSER

Catalog Number 22-4038

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Event Description

It was reported that the first pass suture came out the patient and there was not self capture.Procedure delay was greater than 30 minutes but less than an hour, no patient injuries were reported.

Manufacturer Narrative

Event description was updated.

Event Description

It was reported that when the firstpass suture passer was removed from the patient, there was no self capture component present.The procedure was successfully completed using a back-up device.However, the incident resulted in a surgical delay greater than 30 minutes in order to perform an arthroscopic assessment of joint and fluoroscopy of patient to ensure the missing self capture component was not present in surgical site.No patient injury or other complications were reported.

Manufacturer Narrative

A relationship between the device and reported incident was established based on our visual observations.From the information provided, the fpst came out the patient and there was not self capture.Visual inspection shows the device was received with no suture trap.A needle was found inside the device and no other visual discrepancies were observed.Root cause for missing self capture is due to incorrect assembly or missing during the process.Changes have been implemented to reduce/ eliminate the failure.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: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• 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 drive; austin, TX 78735
• MDR Report Key: 7039305
• MDR Text Key: 93191681
• Report Number: 3006524618-2017-00370
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00817470012309
• UDI-Public: (01)00817470012309(17)190228(10)1138385
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 22-4038
• Device Lot Number: 1138385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2016
• 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: 33 YR