MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL,(BX6); SAW, POWERED, AND ACCESSORIES

Catalog Number 7205345

Device Problem Flaked (1246)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during knee arthroscopy, fragments of the shaver were left within the patient which were unable to be removed.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

The reported boxed incisor plus intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, fragments of the shaver came free from the blade and were left within the patient.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive side-loading during use.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.The boxed incisor plus blades are manufactured and intended as externally communicating devices and are not approved for implantation.Therefore, long term implantation data is not available as it is not specified as an implantable alloy.It remains unknown if corrosion, micro-motion and/or migration of the retained fragments are likely.The impact to the patient is the retained non-implantable fragment of the externally communicating device, possible local irritation and/or discomfort, and additional radiological imaging/exposure cannot be completely ruled out.

• Brand Name: BOXED INCISOR PLUS BL,(BX6)
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8705883
• MDR Text Key: 148268726
• Report Number: 1219602-2019-00709
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251688
• UDI-Public: 03596010251688
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Catalogue Number: 7205345
• Device Lot Number: 50764118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1