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

Catalog Number	7205345
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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.
Additional 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)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8705883
• Report Number: 1219602-2019-00709
• Device Sequence Number: 13914529
• Product Code: HAB
• UDI-Device Identifier: 03596010251688
• UDI-Public: 03596010251688
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/05/2019

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 Expiration Date: 10/11/2023
• Device Catalogue Number: 7205345
• Device Lot Number: 50764118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1