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

Model Number	PSZ-400-305
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Upon further follow-up of the patient, it was indicated that the device tip had migrated and the patient's pain had returned.The physician successfully removed the device tip from the patient.A posterior fusion was performed on the patient.

• Brand Name: ANCHORKNOT SUTURE PASSER (2-0)
• Common Device Name: MANUAL ARTHROSCOPIC INSTRUMENTS
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, H4T 1 A1; CA H4T 1A1
• MDR Report Key: 8849094
• Report Number: 9710452-2019-00017
• Device Sequence Number: 16823441
• Product Code: HRX
• UDI-Device Identifier: 00685447001744
• UDI-Public: (01)00685447001744(17)211028(10)PZFA030818
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: PSZ-400-305
• Device Lot Number: PZFA030818
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other