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

Model Number 72202403

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

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

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).Preliminary results of investigation showed: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted. a visual inspection found that the shaft has been driven through the anchor plug breaking the tip of the plug.The anchor was not returned with the device. a functional evaluation revealed that the torque limiter functioned properly.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip, attempted correction of a damaged device, or an inadvertent impact event.No containment or corrective actions are recommended at this time.

Event Description

It was reported that the anchor of the bioraptor knotless suture was not working.It is unknown if a delay happened, when the issue was discovered and if a backup device was available.However, no patient injuries were reported.Results of investigation have concluded that this device had the tip of the plug broken.

Manufacturer Narrative

The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.A review of the polymer found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A visual inspection found that the shaft has been driven through the anchor plug breaking the tip of the plug.The anchor was not returned with the device.A functional evaluation revealed that the torque limiter functioned properly.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip, attempted correction of a damaged device, or an inadvertent impact event.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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: 12543395
• MDR Text Key: 273675628
• Report Number: 1219602-2021-02158
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010651273
• UDI-Public: 03596010651273
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K093428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• 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: 204217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2021
• 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: Initial
• Patient Sequence Number: 1