MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRSPR ALGTR STR 2.7MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	011020
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during knee arthroscopy, device front handle piece was bent in back position therefore it did not come forward, it was stuck in a locked position and will not open up, this happened while a surgeon was trying to retrieve a loose body in a patient, shaft looked warped.Procedure was completed with a competitor device.There was no significant delay and no patient injuries were reported.
Additional Manufacturer Narrative
One 2.7 mm alligator grasper was returned for evaluation.Visual assessment of the device confirmed the reported complaint of disassembly.The front-end has come free from the handle.Removal of the setscrew that holds the front-end in the handle was found to be deformed.This condition is consistent with excessive force being applied causing the frontend to over-ride the setscrew resulting in its disassembly from the handle.

• Brand Name: GRSPR ALGTR STR 2.7MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8376399
• Report Number: 1219602-2019-00248
• Device Sequence Number: 1975817
• Product Code: NBH
• UDI-Device Identifier: 03596010022967
• UDI-Public: 03596010022967
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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 Catalogue Number: 011020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1