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

Model Number	7205345
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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.
Additional Manufacturer Narrative
Ten unused boxed incisor blades, intended for use in treatment, were returned for evaluation.The used devices were not returned which prohibits confirmation of the customer complaint.The returned unused devices were tested per tspec blade/burr shedding test 1210265 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.Further investigation is not warranted at this time.

• 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: 9373957
• Report Number: 1219602-2019-01483
• Device Sequence Number: 14225590
• Product Code: HAB
• UDI-Device Identifier: 03596010251688
• UDI-Public: 03596010251688
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 02/11/2020

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
• Operator of Device: 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?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1