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

Model Number 72202403

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Rupture (2208)

Event Date 08/16/2022

Event Type  Injury  

Event Description

It was reported that, during a shoulder arthroscopy, three (3) bioraptor knotless suture anchors did not find a hold and leaked.The original drill was used.A total of three bone holes were drilled.The doctor removed the debris and performed a freshening, so proper anchor placement should be ensured.The procedure was cancelled, two lot numbers were provided (2052042, 2075648) but it is unknown which contributed with the cancellation of the procedure.No further complications were reported.Current health status of the patient is very good.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

B5, d4 and h4, h6 (health effect - clinical and impact codes) were updated.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.This case reports three failed placement attempts for the bioraptor knotless suture anchors during a shoulder arthroscopy procedure.The operative report was provided for review and confirms that three anchors ¿slips out¿ and must be removed from the patient.While it is unknown what size drill the surgeon started the procedure with, the report documents that following the second failed the device, ¿the creation of a new drill hole in the 900 position with a smaller 2.2mm accufex drill bit to give the anchor a better hold.¿ the operative report also notes that following the third attempt, ¿since there is now no longer a sufficiently stable glenoid edge, stabilization must be aborted in order to generate a new bone stock.¿ all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the information provided user vs procedural variance cannot be ruled out a contributing factor to the reported events.The device ifu 10600479_g notes that, ¿to prepare the insertion site, only use the appropriate smith & nephew drill guides and drill bits intended for use with the bioraptor knotless suture anchor to ensure that the implant is properly aligned.¿ the ifu documents that for shoulder placement 72201395 (spade drill bit) is recommended and the surgeon chose to use an accufex drill bit.It has been communicated that the patient health status is ¿very good.¿ no further clinical/medical assessment is warranted at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Event Description

It was reported that, during a shoulder arthroscopy, two bioraptor knotless suture anchors did not find a hold and leaked.The original drill was used and a total of two additional bone holes had to be drilled.The doctor removed the debris and performed a freshening, so proper anchor placement should be ensured, however, the procedure had to be cancelled.No voids were left in the tissue and no further complications were reported.Current health status of the patient is very good.

• 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: 15575336
• MDR Text Key: 301500098
• Report Number: 1219602-2022-01505
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010651273
• UDI-Public: 03596010651273
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202403
• Device Catalogue Number: 72202403
• Device Lot Number: 2075648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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 Outcome(s): Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Male