MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYOVAC(R) SUCTION PUNCH 3.4MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	2707
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 the surgery it is hard to open/close the tip.No patient injuries and complications were reported.No back up device was available.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.
Additional Manufacturer Narrative
One 3.4 suction punch was returned for evaluation.Visual assessment of the device showed no abnormalities.The device was functionally tested per print and was found to function as intended.Reported complaint of the device opening and closing hard could not be confirmed.

• Brand Name: DYOVAC(R) SUCTION PUNCH 3.4MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8420091
• Report Number: 1219602-2019-00304
• Device Sequence Number: 2171104
• Product Code: NBH
• UDI-Device Identifier: 03596010111067
• UDI-Public: 03596010111067
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2019

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: 2707
• Device Lot Number: 50687067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/08/2019; 05/08/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/09/2019; 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1