MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA TI 4.5 W/2 UB (WH & BLUE); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202893
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2024
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 rotator cuff repair, when the twinfix ultra was inserted and screwed in, it broke inside of the patient, leaving half of the implant inside of the patient.The procedure was completed with a surgical delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
A device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 review of the device drawings found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.A clinical review states that 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".Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 review of the device drawings found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.A clinical review states that 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".Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.A visual inspection of the returned device found that it is in its original unopened packaging.The device is undamaged.Based on the condition of the product material found during visual inspection, additional material testing is not required.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: TWINFIX ULTRA TI 4.5 W/2 UB (WH & 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: 18895335
• Report Number: 1219602-2024-00477
• Device Sequence Number: 20730130
• Product Code: MBI
• UDI-Device Identifier: 03596010652287
• UDI-Public: 03596010652287
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2024

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: 72202893
• Device Lot Number: 2109669
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 06/17/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/18/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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 Sex: Male