MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ELITE PREMIUM ALLIGATOR GRASPER; ACCESSORIES,ARTHROSCOPIC

Model Number	72201180
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a knee arthroscopy, the alligator grasper's top jaw broke off as the surgeon was trying to retrieve a lose body from the joint.There was a backup device available.No significant delay or further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
D4: information updated.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 an isolated event.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 images showing the separated jaw of the device laying next to the rest of the front end assembly.A third image was zoomed in on the product identification information, confirming the part number as 011020 and the device name as 2.7mm alligator grasper.A visual inspection of the device found that it was returned outside of its original packaging.The laser etching on the side is worn from use, and confirms the part number as 011020 and the device name as 2.7mm alligator grasper.The top jaw was not returned with the rest of the device.The actuator is still connected to the hinge where the top jaw was, but the metal is fractured.The complaint was confirmed.Factors that could have contributed to the reported event, include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an 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.Internal complaint reference: (b)(4).

• Brand Name: ELITE PREMIUM ALLIGATOR GRASPER
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10617391
• Report Number: 1219602-2020-01503
• Device Sequence Number: 11397050
• Product Code: NBH
• UDI-Device Identifier: 03596010594440
• UDI-Public: 03596010594440
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: 72201180
• Device Catalogue Number: 011020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention