MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HOOK PROBE 2.2MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 3312

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/19/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during an ankle arthroscopy, the hook probe broke while in use for removing a radiofrequency fragment.The specialist tried to remove the piece increasing the pressure on the pump, but it was not possible to know its exact location and made the decision to open to explore.X rays were taken but the tip of the probe could not be found, so the specialist decided to close.The procedure was completed with a back up device with a three hour delay.The patient's health is still to be confirmed.

Manufacturer Narrative

H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 clinical review states that based on the limited information provided, the clinical root cause of the reported breakage of the microblator could not be definitively concluded, the root cause of the hook probe was the attempted removal of microblator fragment.The hook probe is an external communicating device composed of surgical stainless steel that is neither manufactured nor intended for implantation and should have limited tissue/bone contact as long term implantation data is not available.Since the broken piece of the hook probe is unknown location its possible its retained within the patient, the potential for micromotion and/or migration cannot be ruled out.Additionally, the open procedure and prolonged anesthesia time increases the risk for post-surgical complications and possibly recovery time for the patient.No further clinical assessment is warranted at this time.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: HOOK PROBE 2.2MM
• Type of Device: 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: 17908328
• MDR Text Key: 325317582
• Report Number: 1219602-2023-01950
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010115577
• UDI-Public: 03596010115577
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 3312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/21/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Male