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

Catalog Number	72202397
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a hip labral repair, two bioraptor knotless anchors failed the same way.The internal anchor suture locking mechanism failed to deploy and broke inside of the body of the anchor, therefore, it would not secure the sutures and the anchor pulled out of the bone.The pieces were still inside the large body of the anchor and pulled out along with the suture.No pieces fell inside of the patient.The procedure was completed with 30 minutes of surgical delay using a smith and nephew back-up device on an additional bone hole.No further complications were reported.
Additional Manufacturer Narrative
H10 h3, h6: part of the devices, used in treatment, were received for evaluation.A visual inspection of the returned devices found that they are not in their original packaging.The insertion devices were returned with no stay sutures or anchors.A functional evaluation was performed on the returned device and found the torque limiters on the proximal end of the device and the attached shafts function as designed.Based on the condition of the product material found during visual inspection, no fracture of the implant could be confirmed.Additional material testing is not required.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.A review of the material specifications found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.The root cause was not determined since the reported malfunction could not be duplicated during the product evaluation process.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 HIP
• Common Device Name: 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: 17927751
• Report Number: 1219602-2023-01973
• Device Sequence Number: 17720024
• Product Code: MBI
• UDI-Device Identifier: 03596010651280
• UDI-Public: 03596010651280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2025
• Device Catalogue Number: 72202397
• Device Lot Number: 2049680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown