MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA TI 5.5 W/3 UB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202897
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during an unspecified surgery, the screw holder of the twinfix ultra broke.No surgical delay was reported; however, it is unknown how the procedure was completed.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received incomplete for evaluation; only a portion of it was provided.Additionally, an unused device was also received.A visual inspection of these devices revealed one that is not in its original packaging.The outer box is opened but the interior poly bag is sealed and contains an unused insertion device with anchor and sutures in place.There is a portion of the distal end of the insertion shaft of one device taped to the outer box.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 root cause was associated with unintended use of the device.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.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX ULTRA TI 5.5 W/3 UB
• 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: 19655970
• Report Number: 1219602-2024-01413
• Device Sequence Number: 20489029
• Product Code: MBI
• UDI-Device Identifier: 03596010652317
• UDI-Public: 03596010652317
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 72202897
• Device Lot Number: 2143004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2024
• 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 Sex: Unknown