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

Catalog Number 72202403

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that, during an arthroscopy, the bioraptor anchor broke and deformed while being implanted.The procedure was successfully completed without surgical delay using a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.An image evaluation was performed and found the anchor is out of the insertion device.The anchor does not seem broken or deformed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported event.A review of the material specifications found that the anchor is out of the insertion device.The anchor does not seem broken or deformed.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.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• 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: 18383654
• MDR Text Key: 331215615
• Report Number: 1219602-2023-02505
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K083635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202403
• Device Lot Number: 2115904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2024
• Date Device Manufactured: 03/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male