MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. ANCHORKNOT SUTURE PASSER (2-0) MANUAL ARTHROSCOPIC INSTRUMENTS

Model Number PSZ-400-305

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

The risk assessment of the device identifies a potential failure mode of tip breakage in cases of user-applied torque/excessive forces to the device tip. The device instructions for use includes the following statements: as with any surgical instrument, careful attention should be paid to ensure that excessive force is not placed on this instrument. Excessive force can result in failure to deliver suture. Do not apply excessive forces, including forces (torque) to the tip of the suture passer, as this could result in detachment of the device tip.

Event Description

The anchorknot suture passer was used in a herniated disc repair procedure. Upon placement of the suture passer, the device was torqued and the tip broke off within the disc. At this time, the first trigger had not been pulled and the suture was not deployed. The physician attempted to retrieve the broken tip using a nerve hook and a micro pituitary rongeur. X-rays views were taken that showed the broken tip within the disc space. The physician then decided to leave the tip where it was and close. The physician later confirmed that an unsuccessful attempt was made to retrieve the tip. Subsequently the physician determined through x-ray imaging intraoperatively that the tip was fully contained within the disc space and there was limited risk of migration and he decided to leave the tip within the disc. In a follow-up x-ray image, it was noted that the device tip had migrated to the anterior portion of the left pedicle. No complications were associated with the device migration. No other adverse effects were reported. The physician enquired about the mri compatibility of the tip materials, and was informed that the device is manufactured with materials that are not mri-compatible.

• Brand Name: ANCHORKNOT SUTURE PASSER (2-0)
• Type of Device: MANUAL ARTHROSCOPIC INSTRUMENTS
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2775 matheson blvd. east; mississauga, L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: meghal khakhar ; 2775 matheson blvd. east; mississauga, ontario L4W 4-P7 ; CA L4W 4P7
• MDR Report Key: 8849094
• MDR Text Key: 152912460
• Report Number: 9710452-2019-00017
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/28/2021
• Device Model Number: PSZ-400-305
• Device Lot Number: PZFA030818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 07/31/2019 Patient Sequence Number: 1