MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CUFF STITCH 180 DEG LEFT; ACCESSORIES,ARTHROSCOPIC

Model Number 7209161

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2020

Event Type  Injury  

Event Description

It was reported that during shoulder procedure, the cuff stitch broke when forced inside the labrum.The pieces were successfully removed from the patient.No delay and the procedure was finish with the same device.No other complications were reported.

Manufacturer Narrative

H10: h2, h6.The reported 180 degree cuff stitch left, used in treatment, will not be returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information reported, cuff stitch broke when forced inside the labrum.Per the device instructions for use: as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

H10: h2: additional information: 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 visual inspection found the tip of the device is broken off.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.The complaint was confirmed, and 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, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: CUFF STITCH 180 DEG LEFT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 10302415
• MDR Text Key: 199692302
• Report Number: 1219602-2020-01091
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010448927
• UDI-Public: 03596010448927
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• 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: 01/31/2023

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: 7209161
• Device Catalogue Number: 7209161
• Device Lot Number: 50293346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 06/29/2020; 01/30/2023
• Supplement Dates FDA Received: 08/31/2020; 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female