MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BLADE,5.5MM,DSPL,6BX; SAW, POWERED, AND ACCESSORIES

Model Number	72200081
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International zip code: (b)(6).
Event or Problem Description
It was reported that during a knee arthroscopy the tip of the blade broke off, ending up in the space between the distal end of the femur and the proximal end of the tibia.The pieces of the blade was removed using basket tweezers.It is unknown if there was a delay or back-up device available.No patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 5.5 incisor plus elite blade, used in treatment, has been returned for evaluation.Functional inspection confirmed the inner blade does not rotate freely within the outer blade, friction was felt in the unloaded condition.Visual assessment of the device showed the outer blade is bent.There are visual signs of material galling at the first and fourth edge form teeth.Both tips of the device are intact.All indications point an excessive lateral load applied during use causing the edge form teeth of the inner blade to contact the outer blade causing the observed shedding.Per the device ifu 1060595 under precautions ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿.A review of the manufacturing and complaint records was performed for the reported lot, 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.
Additional Manufacturer Narrative
H10: a2: patient age added a3: patient sex added a4: patient weight added b5: event description updated.
Event or Problem Description
It was reported that during a knee arthroscopy the tip of the blade broke off, ending up in the space between the distal end of the femur and the proximal end of the tibia.The pieces of the blade were removed using basket tweezers.No significant delay reported, the procedure was completed with the same device.
Additional Manufacturer Narrative
The reported 5.5mm incisor plus elite blade, intended for use in treatment, have not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the tip of the blade broke off 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¿ on the blade during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lots, 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: INCISOR PLUS ELITE BLADE,5.5MM,DSPL,6BX
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9673205
• Report Number: 1219602-2020-00180
• Device Sequence Number: 16223084
• Product Code: HAB
• UDI-Device Identifier: 03596010555687
• UDI-Public: 03596010555687
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/21/2020

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: 08/04/2024
• Device Model Number: 72200081
• Device Catalogue Number: 72200081
• Device Lot Number: 50798556
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 03/09/2020; 04/27/2020; 05/21/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/18/2020; 05/04/2020; 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 85