MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/2 UB-WHT & BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202599
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an arthroscopy, when the screw was twist in, the twinfix ultra anchor's head broke because the cortical was too hard and the direction was changed.Surgery was completed with a back-up device instead.There was a surgical delay greater than 30 minutes, and no further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed that the returned device was not in its original packaging.The insertion device was returned with the anchor and suture strings on the device, the anchor fractured at the proximal end of the suture window.There is biological debris on the returned items.An assessment of material characteristics found that based on the condition of the product material found during visual inspection, 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.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 tensile strength requirements are specified.A material certificate of analysis is required for raw material.A clinical review states that 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 solely on the results of the product evaluation the root cause of the reported issue was the result of a user vs procedural variance.The twinfix anchors are implantable, biocompatibility is not an issue if broken fragments were retained in the patient.If broken fragments were retained in the patient micro-motion or movement cannot be predicted and there is potential risk for tissue inflammation and/or pain.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive force or torque on the device or off-axis insertion.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/2 UB-WHT & BL
• 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: 19165697
• Report Number: 1219602-2024-00862
• Device Sequence Number: 7856080
• Product Code: MBI
• UDI-Device Identifier: 03596010647474
• UDI-Public: 03596010647474
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2024

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: 72202599
• Device Lot Number: 2101827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Male