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

Catalog Number	72202895
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that during set up for a procedure, shortly before the implantation, it was noticed that the twinfix titanium anchor could not be screwed in and was sitting loosely on the applicator.The procedure was delayed for less than 30 minutes.Back up device was available.As per the preliminary results of the investigation, the visual inspection shows the insertion device was returned with the distal end fractured away from the shaft.
Event or Problem Description
It was reported that during set up for a procedure, shortly before the implantation, it was noticed that the twinfix titanium anchor could not be screwed in and was sitting loosely on the applicator.The procedure was delayed for less than 30 minutes.Back up device was available.As per the results of the investigation, the visual inspection shows the insertion device was returned with the distal end fractured away from the shaft.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The insertion device was returned with the distal end fractured away from the shaft.The anchor and suture strings were still in position on the fractured tip of the inserter shaft.There is biological debris on the used items.A functional evaluation could not be performed on the device due to it being broken.There was a relationship found between the device and the reported event.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.The complaint was confirmed, and 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, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX ULTRA 5.5MM W/2 UB (WHT & BLUE)
• 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: 18139426
• Report Number: 1219602-2023-02234
• Device Sequence Number: 15057914
• Product Code: MBI
• UDI-Device Identifier: 03596010652263
• UDI-Public: 03596010652263
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/15/2024

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: 72202895
• Device Lot Number: 2118132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2023
• 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 Sex: Unknown