MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 ULTRABRAID; STAPLE, FIXATION, BONE

Catalog Number	72200750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy, the thread of the twinfix suture broke when the surgeon was tying the knot.The anchor remained inside the patient's bone and an additional bone hole was drilled.The procedure was completed with non-significant delay using a smith and nephew back up devices.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).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.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 suture material found that the storage specifications are documented and a material certificate is required with each lot.A clinical review states that it is unknown if the implantable broken thread of the twinfix suture was left secure, consequently, micro-motion/and or migration, the potential risk for tissue inflammation and/or pain from the broken thread cannot be ruled out.No further complications were reported.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: TWINFIX TI 2.8 ULTRABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 17805208
• Report Number: 1219602-2023-01840
• Device Sequence Number: 15135357
• Product Code: JDR
• UDI-Device Identifier: 03596010584472
• UDI-Public: 03596010584472
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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 Catalogue Number: 72200750
• Device Lot Number: 2093556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 09/24/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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 Age: 18 YR
• Patient Sex: Male