MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIRPTR 2.3 PK SUTURE ANCHOR W/ ULTRAB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72201541
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy, the bioraptor suture anchor got pulled out when the surgeon pulled the suture during the knot.The procedure was completed with a smith and nephew back up device in an additional bone hole using a twist drill 2.45 mm of bioraptor to prepare the insertion site and leaving a void in the patient.There was a delay less than 30 minutes and no further complications were reported.The patient is fine.
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
H10: 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.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.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.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 clinical review states a user technique/procedural variance cannot be definitively ruled out as a potential contributing factor.The patient impact is determined to be the suture anchor pull-out which resulted in use of a backup device in an additional bone hole.Further complications would not be anticipated in a young male patient with good bone quality.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.If any additional information related to this event is received in the future, this investigation will be reopened for further assessment.H12: h2: corrected data on h1 (type of reportable event).
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual inspection revealed that it was returned in original packaging with the batch number of the complaint on the label.The anchor was returned off the device with no visible defect other than bio debris.No sutures were returned, and the insertion device has no visible defect.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.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.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 clinical review states that the ifu includes importance of site prep, alignment, and avoidance of excessive force in addition to warnings/precautions/instructions.A clinical root cause could not be determined based on the limited information provided; however, a user technique/procedural variance cannot be definitively ruled out as a potential contributing factor.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure 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, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.

• Brand Name: BIRPTR 2.3 PK SUTURE ANCHOR W/ ULTRAB
• 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: 20046155
• Report Number: 1219602-2024-01809
• Device Sequence Number: 7955640
• Product Code: MBI
• UDI-Device Identifier: 03596010595072
• UDI-Public: 3596010595072
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 03/03/2026

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: 72201541
• Device Lot Number: 2129958
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 02/27/2026
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/04/2024; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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: 33 YR
• Patient Sex: Male