MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR KNOTLESS SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202403

Device Problems Mechanical Problem (1384); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

It was reported that, during a shoulder scope, two bioraptor were put in and they were to tension the device and place it, the wheel was not working and the sutures did not locked.The procedure was completed with a s+n back up device.There was a non-significant delay and no further complications were reported.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H11: internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the reported device was not received, however 11 devices from the same lot number returned for evaluation.A visual inspection of the returned devices found the 11 devices in original unopened packaging.Three devices were evaluated.Device 1 - a functional evaluation revealed that the torque limiter functioned properly.Device 2 - a functional evaluation revealed that the torque limiter functioned properly.Device 3 - a functional evaluation revealed that the torque limiter functioned properly.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

• Brand Name: BIORAPTOR KNOTLESS SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14219927
• MDR Text Key: 290171611
• Report Number: 1219602-2022-00600
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010651273
• UDI-Public: 03596010651273
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202403
• Device Catalogue Number: 72202403
• Device Lot Number: 2080607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1