MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 ULTRABRAID; STAPLE, FIXATION, BONE

Catalog Number 72200750

Device Problem Break (1069)

Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported that during an arthroscopy, the twinfix eye of the anchor broke off during implantation.A broken piece of the anchor with the eye and threads remained in the inserter; however, a fragment could not be extracted and was left secured in the patient's bone.The procedure was completed using a smith and nephew back up device near the original drilled bone hole; a void was left in the patient.There was a surgical delay less than 30 minutes and no further complications were reported.

Manufacturer Narrative

H10: internal complaint reference number: (b)(4).

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 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 blueprints 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 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 twinfix anchors are implantable, biocompatibility is not an issue.Micromotion and/or migration is unlikely as it was noted that the fragment was left secure in the patient.No further risk to the patient is anticipated as a result of the additional bone hole.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 TI 2.8 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• 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: 18847243
• MDR Text Key: 337016721
• Report Number: 1219602-2024-00405
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010584472
• UDI-Public: 03596010584472
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K152566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200750
• Device Lot Number: 2103584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 80 KG