MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE LONG 4.5MM; SAW, POWERED, AND ACCESSORIES

Model Number	72200414
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a hip arthroscopy surgery, the incisor plus elite broke off inside the patient's anatomy.No delay was reported.It is unknown if there was a smith and nephew back-up device available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during a hip arthroscopy surgery, the incisor plus elite broke off inside the patient.All the broken pieces were removed from the patient's anatomy and there was no delay reported.It is unknown if there was a smith and nephew back-up device available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One used incisor plus elite long 4.5mm has not returned for evaluation.Without the reported product, a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.The information provided states that ¿during a hip arthroscopy surgery, the incisor plus elite broke off inside the patient¿.An exact root cause cannot be determined with confidence without the pertinent clinical details; however, factors that could have contributed to the reported event include: excessive force.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during a hip arthroscopy surgery, the incisor plus elite broke off inside the patient.All the broken pieces were removed from the patient's anatomy and there was no delay reported.It is unknown if there was a smith and nephew back-up device available to complete the surgery.
Additional Manufacturer Narrative
B5 and h6 (health effect - impact code) updated.H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A visual inspection found the device is slightly bent and the inner shaft is broken into two pieces.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.The complaint was confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: INCISOR PLUS ELITE LONG 4.5MM
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10397255
• Report Number: 1219602-2020-01235
• Device Sequence Number: 16812045
• Product Code: HAB
• UDI-Device Identifier: 03596010553850
• UDI-Public: 03596010553850
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: 72200414
• Device Catalogue Number: 72200414
• Device Lot Number: 50823353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 08/18/2020; 09/18/2020; 11/04/2021
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 08/26/2020; 09/21/2020; 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male