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

Model Number 72202895

Device Problem Corroded (1131)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  Injury  

Event Description

It was reported that during shoulder rotator cuff repair surgery, it was rust in the laser marking on the inserter.No significant delay and a back up was available to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during shoulder rotator cuff repair surgery, the twinfix was rust in the laser marking on the inserter.No significant delay and a back up was available to complete the procedure.No other complications were reported.Current health status of the patient is good.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H2: additional information: b5 and h6: health effect - clinical and impact code.H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the part drawing found that the shaft is visually inspected for deformities.The shaft is now passivated after laser marking.A certificate of conformance for evidence of passivation is required.This design change was implemented as a result of a corrective action to address the reported issue.¿ a visual inspection of the returned device found that it is not in its original packaging.The device has been deployed, and the anchor and sutures were not returned.There is discoloration resembling corrosion on the laser markings of the device.A review of the customer provided image found an arthroscopic view of the device in use.A discoloration resembling corrosion can be seen in the laser markings of the device.One undated photo was provided for review and confirms a color variation.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.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 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: 10819329
• MDR Text Key: 215606159
• Report Number: 1219602-2020-01817
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010652263
• UDI-Public: 03596010652263
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100159
• 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
• Report Date: 12/16/2022

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 Expiration Date: 03/30/2023
• Device Model Number: 72202895
• Device Catalogue Number: 72202895
• Device Lot Number: 50724179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2018
• 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): Other