MAUDE Adverse Event Report: ARTHROCARE CORP. DISPOSABLE FIRSTPASS SUTURE PASSER, SELF

Model Number 22-4038

Device Problem Positioning Failure (1158)

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

Event Date 04/20/2020

Event Type  Injury  

Event Description

It was reported that during an arthroscopy the first-pass suture was not passing through the rotator cuff.The needle was bent.The procedure was completed using an smith & nephew accupass device.A delay of 10 minutes was reported.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the disposable firstpass suture passer, self device, used in treatment, was returned for evaluation.A relationship between the device and reported incident was not established.A review of manufacturing records for the reported lot number 2040498 found no non-conformance's or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.Visual inspection shows no manufacturing abnormalities on the device.The instrument was returned with a closed top bracket.The needle is bent.The first step of the trigger stayed locked in the closed position and cannot be released.An attempt was made to test the basic functions of the instrument but due to the damage it is not possible.The complaint was verified.An exact root cause cannot be determined with confidence; however, potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force (2) tissue thickness (3) debris or damage on the tip between passes.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DISPOSABLE FIRSTPASS SUTURE PASSER, SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10050159
• MDR Text Key: 190757271
• Report Number: 3006524618-2020-00253
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: 22-4038
• Device Lot Number: 2040498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention