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 08/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was report that during a shoulder repair, two anchors were rusty.The procedure was successfully completed without significant delay using a smith and nephew back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.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 review of risk management files found that the reported failure was documented appropriately.A review of the customer provided images found two arthroscopic images of the device being used in treatment.The shaft of the device shows a substance resembling corrosion in both images, however, there is no substance or discoloration seen on the anchor itself, but the substance appears to be spread below the visible surface into the inserter hole of the anchor.A visual inspection of the returned device found that it was returned outside of its original packaging.There is a small amount of discoloration resembling corrosion on the distal end of the shaft.One of the prongs on the distal end of the shaft is bent.The anchor and sutures have been deployed, but were not returned with the device.There is debris on the shaft.A review of the results of the presumptive blood test kit confirmed that the substance on the shaft of the device is not blood.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: 12362642
• MDR Text Key: 267971168
• Report Number: 1219602-2021-01777
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• 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: 2049804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2020
• 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