MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO FERKEL MICROFRACTURE PICK 65; ACCESSORIES,ARTHROSCOPIC

Model Number	72202154
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a mto ferkel microfracture pick 65 was put into the ankle for a micro fracture, bone was soft, so it was easily introduced with minimal force, no hammer needed.On removal from bone the tip of the device broke off inside of the patient.All pieces were recovered requiring extra incisions and x-rays.A delay greater than 30min was reported.No other complications were reported.
Event or Problem Description
It was reported that a mto ferkel microfracture pick 65 was put into the ankle for a micro fracture, bone was soft, so it was easily introduced with minimal force (no hammer needed).On removal from bone the tip of the device broke off inside of the patient.All pieces were recovered requiring extra incisions and x-rays.Procedure was completed using a back-up device.A significant delay (greater than 30min) was reported.No other complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.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 risk management review found that the reported failure was documented appropriately and there were no indications to suggest the anticipated risk is not adequate.No relevant supporting clinical information has been provided to assist with a clinical investigation.Per case details, the broken tip was retrieved from the patient.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A visual inspection revealed the device was returned in outside its original packaging.The broken distal tip was returned in a separate container.The break occurred at the joint where the pick curved in 65 degrees.Indications of blunt force were observed on the bottom of a handle, which appeared most likely to have occurred by the use of a hammer.It was determined the device did not contribute to the reported event.The complaint was confirmed and the root cause associated with an 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, 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: MTO FERKEL MICROFRACTURE PICK 65
• 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: 12583784
• Report Number: 1219602-2021-02222
• Device Sequence Number: 13806966
• Product Code: NBH
• UDI-Device Identifier: 03596010622334
• UDI-Public: 03596010622334
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2022

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: 72202154
• Device Catalogue Number: 72202154
• Device Lot Number: 50428343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 10/21/2021; 02/25/2022
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/25/2021; 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2012
• 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; Other
• Patient Age: 50 YR
• Patient Sex: Male