MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROBE 3MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72203692
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ankle procedure, the tip of the probe broke off inside the patient.All pieces were removed with a grasper.The broken tip was recovered.The procedure was successfully completed without significant delay using other instruments.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 72203692 3mm probe was reported on.The product was not returned for evaluation.This is a seven year old reusable instrument.Due to product unavailability, evaluation was limited.If further information becomes available, the complaint may be revisited.Factors that may affect device performance include: device storage, ability, sterilization, surgical ability, procedure location and tissue condition.Influences unrelated to manufacture that could compromise product performance or integrity include: incompatible force or torque or leverage applied.Change of approach during use.Recommended maintenance not performed.Per ifu 10600629: ¿these instruments are designed for repeated use with proper care and handling.Prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found no similar reported events.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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The markings on the handle of confirm the product identification information.The device is worn from use.The distal tip of the probe is fractured from the device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, an impact event inconsistent with normal use, wear from prolonged use, misuse or rough handling, or inadequate routine maintenance.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.Correction in h6 (health effect - impact code).

• Brand Name: PROBE 3MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• 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: 10500345
• Report Number: 1219602-2020-01366
• Device Sequence Number: 3118638
• Product Code: NBH
• UDI-Device Identifier: 00885554030006
• UDI-Public: 00885554030006
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 01/13/2023

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 Model Number: 72203692
• Device Catalogue Number: 72203692
• Device Lot Number: 50448409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 01/12/2023
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 10/19/2020; 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown