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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL,(BX6); SAW, POWERED, AND ACCESSORIES Back to Search Results
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.
 
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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 Key9373966
MDR Text Key167976555
Report Number1219602-2019-01484
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010251688
UDI-Public03596010251688
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Date01/06/2024
Device Model Number7205345
Device Catalogue Number7205345
Device Lot Number50779865
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Initial Date Manufacturer Received 11/04/2019
Initial Date FDA Received11/26/2019
Supplement Dates Manufacturer Received01/31/2020
Supplement Dates FDA Received02/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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