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

Model Number	72202589
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that during set up or inspection, the suture cutter got stuck.The procedure was successfully completed without delay using a smith and nephew back up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H10, h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A visual inspection revealed the carbide inserts cutter tip appears stuck at the distal tip.The device shows no signs of stress.Appears free of burrs and nicks.A functional evaluation revealed the opening and closing of the jaws could not function as expected.The complaint is confirmed and the root cause is associated with a mechanical component failure.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.Internal complaint reference: (b)(4).

• Brand Name: SUTURE CUTTER
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11859579
• Report Number: 1219602-2021-01187
• Device Sequence Number: 4545497
• Product Code: NBH
• UDI-Device Identifier: 03596010652447
• UDI-Public: 03596010652447
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72202589
• Device Catalogue Number: 72202589
• Device Lot Number: 54254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1