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

Catalog Number	72202403
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy procedure, the respective initiation process was carried out with a 2.9 lancet through a cannula as indicated by the manufacturer.A bioraptor anchor was used, one of the tips was loaded with minitape and the anchor was introduced.This also presented a lot of resistance.It was removed and tried again.However, it was not completely introduced.The anchor broke and a portion remained in the handle where it was assembled.Given these findings, it was decided to change the surgical technique and therefore, the implant.The procedure was completed with a surgical delay greater than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 b5 and b6: event description and bone details updated.
Event or Problem Description
It was reported that during an arthroscopy procedure, the respective initiation process was carried out with a 2.9 lancet through a cannula as indicated by the manufacturer.A bioraptor anchor was used, one of the tips was loaded with minitape and the anchor was introduced.This also presented a lot of resistance.It was removed and tried again.However, it was not completely introduced.The anchor broke and a portion remained in the handle where it was assembled.Given these findings, it was decided to change the surgical technique and therefore, the implants.The procedure was completed with a surgical delay greater than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, images evaluation was performed and found four images identified several devices, with two of the images showing two anchors, both of which appear to be broken.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 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.A review of the material specifications found 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 could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.H11: corrected information in h6 (type of investigation & investigation findings).
Additional Manufacturer Narrative
H10 h3, h6: the reported device, along with another device, was received for evaluation.A visual inspection revealed they were returned together with original packaging with the batch number of the complaint on the label.The anchor body, anchor plug, and sutures were not returned for either device.There is no visible defect on either device.A functional evaluation was performed on the returned devices and found that the torque limiter knob will turn and advance as intended for one device but will only turn and not advance for the other device.A material assessment could not be performed due to the part not being returned for evaluation.An analysis of the customer-provided four images identified several devices, with two of the images showing two anchors, both of which appear to be broken.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 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.A review of the material specifications found 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 for the torque limiter knob not advancing has been associated with a component failure (factors that could have contributed to the failure include excessive force on the device).The root cause for the anchor breakage could not be determined since findings cannot lead to a clear cause of the reported event (factors that could have contributed to the reported event include excessive force on the device, excessive, torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: BIORAPTOR KNOTLESS SUTURE ANCHOR
• 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: 21335347
• Report Number: 1219602-2025-00312
• Device Sequence Number: 18253136
• Product Code: MBI
• UDI-Device Identifier: 03596010651273
• UDI-Public: 3596010651273
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K152566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72202403
• Device Lot Number: 2117497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2025
• Supplement Date Received by Manufacturer: 02/14/2025; 03/20/2025; 03/26/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/20/2025; 03/21/2025; 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2023
• 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
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 73 KG