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

Model Number	010001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that on (b)(6) 2021, during a right ankle arthroscopy procedure, the acufex probe broke.An additional incision was needed to remove the broken piece of the device.As a result, the patient was left with a scar on his ankle measuring approximately 4 inches.It is unknown if there was any delay or backup device.No other complications were reported.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported 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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the customer provided image found multiple images of an foot and ankle with incisions.No images of the device were attached.This case reports that the acufex probe had to be retrieved from the patient through an additional incision due to breakage.The operative report notes that ¿during the micro fracturing process, the end of the probe broke off the tip got lodged behind the talar body¿ and ¿a posteromedial arthrotomy incision was made.¿ it also documents that the ¿broken probe was easily removed.¿ undated photos of the patient¿s ankle were provided for review and shows the location of the additional incision and the scar that remains.The patient impact beyond the reported issues cannot be concluded.No further clinical assessment a thorough medical assessment cannot be rendered at this time.The complaint was not 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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: PROBE STRAIGHT
• 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: 12510132
• Report Number: 1219602-2021-02097
• Device Sequence Number: 14742343
• Product Code: NBH
• UDI-Device Identifier: 03596010021533
• UDI-Public: 03596010021533
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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: 010001
• Device Catalogue Number: 010001
• Device Lot Number: 50438854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 02/03/2022
• 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: Other
• Patient Age: 48 YR
• Patient Sex: Male