MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX-PRO SCISSOR STR; ACCESSORIES,ARTHROSCOPIC

Catalog Number	7207047
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unit was broken.The device broke inside the patient.Procedure was finished with the same device.No patient injury reported.
Additional Manufacturer Narrative
One acufex pro straight scissor punch was returned for evaluation.Visual assessment shows the front-end is free from the handle.The cutting edges are dull and damaged.The set screw that holds the front-end in the handle is deformed.Examination of the handles finger loop showed the actuator slot is also deformed.The device is over 5 years old and is worn.The condition of the device indicates excessive forces were placed on it causing the front-end to disengage from the handle.In addition a dull cutting edge such as this would require excessive force to cut.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.

• Brand Name: ACUFEX-PRO SCISSOR STR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8086174
• Report Number: 1219602-2018-01585
• Device Sequence Number: 1326640
• Product Code: NBH
• UDI-Device Identifier: 03596010252906
• UDI-Public: 03596010252906
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 7207047
• Device Lot Number: 50467396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1