MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTURE CUTTER; ACCESSORIES,ARTHROSCOPIC

Model Number 72202589

Device Problems Corroded (1131); Mechanical Jam (2983)

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

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the sample is under evaluation by the manufacturing site.

Event Description

It was reported that, the head position of the suture cutter, does not pass through the wire.It is unknown when the issue was found.Backup device was available to complete the procedure.No delay and no patient injuries were reported.Preliminary results of investigation have concluded that this unit had rust and debris which makes it a reportable event since indicates the device was used in the patient.

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed it was returned outside of original packaging.The cutter appears jammed at the distal tip.Rust debris appears at the cutter site.Debris in the cutter blade tip.A functional evaluation was performed on the returned device and found it could not be functioned as intended as cutter jammed at the distal tip.A review of the customer provided image reveals the distal tip of the device appears to be jammed.There was a relationship found between the returned device and the reported incident.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 no similar reported events.The instructions for use were 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.The root cause has been associated with failure to follow instructions.Factors that could have contributed to the failure include a buildup of corrosion/debris from cleaning or chemical fluid ingress over time.No containment or corrective actions are recommended at this time.

• Brand Name: SUTURE CUTTER
• 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: 12297904
• MDR Text Key: 265777340
• Report Number: 1219602-2021-01688
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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: 72202589
• Device Catalogue Number: 72202589
• Device Lot Number: 50978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2019
• 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): Other
• Patient Sex: Male
• Patient Weight: 80 KG