MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN DISPOSABLE BLADE AND BURR; SAW, POWERED, AND ACCESSORIES

Catalog Number UNKNOWN

Device Problem Flaked (1246)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported that the dyonics shaver blade leave hundreds of small metal fragments behind in the patient.It is unknown if there was a back-up device available or if there was a surgical delay.No further complications reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, instruction for use review, risk management review, could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A clinical review states that the burrs and blades are manufactured and intended as externally communicating devices; therefore, long-term implantation data is not available.The material composition would be surgical stainless steel, however, without the actual product identifier(s), the exact composition of the externally communicating devices cannot be confirmed.Although side-loading is a known factor which can contribute to metallic flaking/shedding, definitive contributing clinical factors cannot be concluded based on the limited information provided from the medwatch form and a device malperformance cannot be confirmed.The current patient status is unknown and the patient impact beyond the reported foreign body debris/non-implantable ¿device embedded in tissue or plaque¿ cannot be determined.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKN DISPOSABLE BLADE AND BURR
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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: 18474913
• MDR Text Key: 332435998
• Report Number: 1219602-2024-00069
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other