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U.S. Department of Health and Human Services

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

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BAYLIS MEDICAL COMPANY INC. ANCHORKNOT SUTURE PASSER (2-0) MANUAL ARTHROSCOPIC INSTRUMENTS Back to Search Results
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.
 
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Brand NameANCHORKNOT SUTURE PASSER (2-0)
Type of DeviceMANUAL 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 Key8849094
MDR Text Key152912460
Report Number9710452-2019-00017
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161878
Number of Events Reported1
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 Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2021
Device Model NumberPSZ-400-305
Device Lot NumberPZFA030818
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 Received07/02/2019
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
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