MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202595

Device Problem Corroded (1131)

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

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an arthroscopy, inside of the patient, there was rust between the nail body and metal rod of the twinfix.The procedure was successfully completed with 30 minutes of delay, after pulling it out, and fix it again with 5.5 external anchor.No other complications were reported.

Event Description

It was reported that during an arthroscopy, inside of the patient, there was rust between the nail body and metal rod of the twinfix.The procedure was successfully completed with a 30 minutes delay, after pulling the anchor out, and fix it again with a 5.5 external anchor.No other complications were reported.

Manufacturer Narrative

H2: additional information ¿b5, e1¿.

Manufacturer Narrative

Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the part drawing found that a design change was implemented as part of a corrective action to preserve the quality of the device.The shaft is visually inspected for deformities, and a certificate of conformance for evidence of passivation is required.A review of the customer provided image found an arthroscopic view of the device in use.There is a brown discoloration on the laser marking of the device, but the substance cannot be identified in the image.A visual inspection of the returned device found that it is not in its original packaging.The anchor and sutures were not received with the device.There are no signs of corrosion on the device.There is biological debris on the shaft.The discoloration seen in the customer provided image cannot be seen on the device.The biocompatibility of the color variation material is unknown, and the possibility of localized pain/discomfort, cannot be ruled out if the material or residue from the reported ¿rust¿ remains in the patient.This is presumed to be unlikely with intraoperative surgical awareness and standard irrigation of arthroscopic procedures, but removal is not documented.No further medical assessment can be rendered at this time.The complaint was confirmed, and the root cause was associated with device design.A corrective action for this failure mode is in place.

• Brand Name: TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL
• 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: 13108155
• MDR Text Key: 282894635
• Report Number: 1219602-2021-02792
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010647467
• UDI-Public: 03596010647467
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2022

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
• Device Operator: Health Professional
• Device Model Number: 72202595
• Device Catalogue Number: 72202595
• Device Lot Number: 2056329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 12/31/2022; 02/15/2022
• Supplement Dates FDA Received: 01/14/2022; 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 60 KG