MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72202602
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during a cuff reconstruction and a biceps tenodesis, when the twinfix ultra 5.5mm anchor was inserted, the two wires came loose and the anchor remained in the patient.The procedure was finished with a smith and nephew back up device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.An evaluation of the customer provided images was performed and found the device outside of its package.The inserter has bio debris, and its prongs are bent.Neither the anchor nor the sutures are shown in the images.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 no 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 clinical review states that undated images of the insertion device were provided for review, however they do not indicate a root cause for the reported events.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 on the limited information provided, the clinical root cause of the reported events could not be determined, and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The device ifu does caution that ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device".The twinfix ultra anchors are implantable, biocompatibility is not an issue.If left unsecured in the patient micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further risk to the patient is anticipated as a result of the additional bone hole.The root cause of the reported loose wires and the bent prongs could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the bent prongs include an application of excessive / unintended force on the device.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.

• Brand Name: TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: 18677201
• Report Number: 1219602-2024-00247
• Device Sequence Number: 6194289
• Product Code: MAI
• UDI-Device Identifier: 03596010647573
• UDI-Public: 03596010647573
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151105
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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: 72202602
• Device Lot Number: 2115929
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Male