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)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic cuff suture, the twinfix ultra anchor loosened during implantation.The procedure was completed with non-significant surgical delay using a back-up device.No further complications were reported.The status of the patient is very good.Preliminary results of investigation have concluded that the distal end of the anchor fractured away from the shaft.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopic cuff suture, the twinfix ultra anchor loosened during implantation.The procedure was completed with non-significant surgical delay using a back-up device.No further complications were reported.The status of the patient is very good.Results of investigation have concluded that the distal end of the inserter was fractured away from the shaft.
Additional Manufacturer Narrative
B5 was updated.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.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, 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: 18154618
• Report Number: 1219602-2023-02242
• Device Sequence Number: 12409155
• Product Code: MBI
• UDI-Device Identifier: 03596010652263
• UDI-Public: 03596010652263
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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: 2115950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2023
• 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: 55 YR
• Patient Sex: Female