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

Catalog Number 72202895

Device Problems Break (1069); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2023

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).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.The anchor and suture material were not returned.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 failures and/or harms were documented appropriately, and there were no indications to suggest the anticipated risks are 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.

Event Description

It was reported that, during a shoulder arthroscopy, when the threading was completed, the twinfix ultra anchor disassembled from the handle and internal screw.The anchor was only one turn away from reaching the laser line and remained fixed.The procedure was successfully completed without surgical delay using the same device.No further complications were reported.

• Brand Name: TWINFIX ULTRA 5.5MM W/2 UB (WHT & BLUE)
• Type of Device: 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: 18965129
• MDR Text Key: 338447569
• Report Number: 1219602-2024-00585
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010652263
• UDI-Public: 03596010652263
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 72202895
• Device Lot Number: 2119602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2023
• 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 Sex: Male