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

Model Number 7205345

Device Problem Flaked (1246)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a knee arthroscopy and menisectomy when the surgeon was using the 4.5mm blade, metal shavings were observed in the knee; these were removed by washing them out.A backup device was available to complete the procedure with no significant delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10.H3, h6: ten unused boxed incisor blades, intended for use in treatment, were returned for evaluation.The used device was not returned which prohibits confirmation of the customer complaint.The returned unused devices were tested per tspec blade/burr shedding test and were found to meet specification.From the information provided, the blades shed during use.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 was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Per the provided communications, the retained metal shaving retained in the patient¿s knee were washed out.Additionally, a backup device was used to complete the surgery.Since no further harm is being alleged to this patient, no further clinical/medical assessment is warranted at this time.A review of the manufacturing records and complaint data base was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 9373966
• MDR Text Key: 167976555
• Report Number: 1219602-2019-01484
• 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: 02/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: 7205345
• Device Catalogue Number: 7205345
• Device Lot Number: 50779865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1