MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRSPR CUPD 3.4MM; ACCESSORIES,ARTHROSCOPIC

Model Number	011014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up for a procedure, the grasper was broken.There was a back-up device available and no surgical delay was reported.There was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).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.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 of the returned devices found that they are not in their original packaging.Device 1 has wear from sterilization and use, the laser etchings are legible.The grasping jaws at the distal end are deformed.Device 2 has wear from sterilization and use, the laser etchings are legible.The grasping jaws at the distal end are in their original position.A functional evaluation of the returned devices finds: device 1 the grasping jaws at the distal end are unable to close completely and will not hold test material.The device does not articulate freely.Device 2 the grasping jaws at the distal end are able to grasp the test material appropriately.The device articulates freely.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 wear due to continued use of the device over time, rough sterilization processes, or excessive force during 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: GRSPR CUPD 3.4MM
• Common Device Name: 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: 15470224
• Report Number: 1219602-2022-01430
• Device Sequence Number: 11830634
• Product Code: NBH
• UDI-Device Identifier: 03596010022936
• UDI-Public: 03596010022936
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2023

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: 011014
• Device Catalogue Number: 011014
• Device Lot Number: 50447062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 01/19/2023; 05/01/2023
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 01/19/2023; 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown